A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512

NCT05493111 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AR-15512-LTSS
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to evaluate the safety of topical ophthalmic 0.003% AR-15512 compared to its vehicle dosed twice daily (BID) in subjects with dry eye disease (DED) for 12 months.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (58)

• Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent

  A treatment-emergent adverse event was defined as any event that occurred or worsened on or after the day randomized study intervention was initiated. At each study visit, subjects were verbally asked by clinic staff to report any changes to any aspect of their ocular health. Ocular treatment-emergent adverse events reported by the subject or observed by the investigator were summarized by preferred term for overall incidence calculation. This was a subject-based assessment.

  Day 1 post-treatment, up to Day 365

• Mean Change From Baseline in Heart Rate at Each Study Visit

  Heart rate was measured using manual or automated methods and recorded in beats per minute (bpm). Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit

  Systolic blood pressure was measured using an appropriate sphygmomanometer and recorded in millimeters mercury (mmHg). Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit

  Diastolic blood pressure was measured using an appropriate sphygmomanometer and recorded in millimeters mercury (mmHg). Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Mean Change From Baseline in Overall Average Endothelial Cell Density at Day 365

  Cell density in the central corneal endothelium was assessed using specular microscopy imaging. Overall average cell density was calculated as the average of the average cell densities of three images and was measured in cells per millimeter squared (cells/mm\^2). A negative change from baseline represents a less desirable outcome.

  Baseline (Day 1 pretreatment), Day 365

• Percentage of Subjects With 10 Percent or More Decrease From Baseline in Overall Average Endothelial Cell Density at Study Exit

  Cell density in the central corneal endothelium was assessed using specular microscopy imaging. Overall average cell density was calculated as the average of the average cell densities of three images and was measured in cells per millimeter squared (cells/mm\^2). A decrease from baseline represents a less desirable outcome.

  Baseline (Day 1 pretreatment), Study Exit (Day 365, early termination visit, or unscheduled visit)

• Mean Change From Baseline in Hematology by Visit - Basophil Level

  A small volume of blood was collected and sent to a laboratory for analysis. Basophil level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Basophils to Leukocytes Ratio Reported in Percentage of Cells

  A small volume of blood was collected and sent to a laboratory for analysis. The basophils to leukocytes ratio was reported as the absolute number of basophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Eosinophil Level

  A small volume of blood was collected and sent to a laboratory for analysis. Eosinophil level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Eosinophils to Leukocytes Ratio Reported in Percentage of Cells

  A small volume of blood was collected and sent to a laboratory for analysis. The eosinophils to leukocytes ratio was reported as the absolute number of eosinophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Concentration Level

  A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular hemoglobin concentration level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Level

  A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular hemoglobin level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Volume

  A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular volume was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Erythrocyte Level

  A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Erythrocyte Distribution Width Reported as Percentage of Variation of Cells

  A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte distribution width was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Hematocrit Level

  A small volume of blood was collected and sent to a laboratory for analysis. Hematocrit level was reported as the volume of red blood cells in liters (L) divided by the volume of blood in L. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Hemoglobin Level

  A small volume of blood was collected and sent to a laboratory for analysis. Hemoglobin level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Leukocyte Level

  A small volume of blood was collected and sent to a laboratory for analysis. Leukocyte level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Lymphocyte Level

  A small volume of blood was collected and sent to a laboratory for analysis. Lymphocyte level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells

  A small volume of blood was collected and sent to a laboratory for analysis. The lymphocytes to leukocytes ratio was reported as the absolute number of lymphocytes divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Monocyte Level

  A small volume of blood was collected and sent to a laboratory for analysis. Monocyte level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Monocytes to Leukocytes Ratio Reported in Percentage of Cells

  A small volume of blood was collected and sent to a laboratory for analysis. The monocytes to leukocytes ratio was reported as the absolute number of monocytes divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Neutrophil Level

  A small volume of blood was collected and sent to a laboratory for analysis. Neutrophil level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Neutrophils to Leukocytes Ratio Reported in Percentage of Cells

  A small volume of blood was collected and sent to a laboratory for analysis. The neutrophils to leukocytes ratio was reported as the absolute number of neutrophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Platelet Level

  A small volume of blood was collected and sent to a laboratory for analysis. Platelet level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Hematology by Visit - Mean Platelet Volume

  A small volume of blood was collected and sent to a laboratory for analysis. Platelet volume was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Alanine Aminotransferase Level

  A small volume of blood was collected and sent to a laboratory for analysis. Alanine aminotransferase level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Albumin Level

  A small volume of blood was collected and sent to a laboratory for analysis. Albumin level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Alkaline Phosphatase Level

  A small volume of blood was collected and sent to a laboratory for analysis. Alkaline phosphatase level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Aspartate Aminotransferase Level

  A small volume of blood was collected and sent to a laboratory for analysis. Aspartate aminotransferase level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Calcium Level

  A small volume of blood was collected and sent to a laboratory for analysis. Calcium level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Creatinine Level

  A small volume of blood was collected and sent to a laboratory for analysis. Creatinine level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Globulin Level

  A small volume of blood was collected and sent to a laboratory for analysis. Globulin level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Potassium Level

  A small volume of blood was collected and sent to a laboratory for analysis. Potassium level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Protein Level

  A small volume of blood was collected and sent to a laboratory for analysis. Protein level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Sodium Level

  A small volume of blood was collected and sent to a laboratory for analysis. Sodium level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Triglyceride Level

  A small volume of blood was collected and sent to a laboratory for analysis. Triglyceride level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Chemistry by Visit - Urea Nitrogen Level

  A small volume of blood was collected and sent to a laboratory for analysis. Urea nitrogen level was measured. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Urinalysis by Visit - Specific Gravity Level

  A small volume of blood was collected and sent to a laboratory for analysis. Specific gravity level was calculated by dividing the sample's density by the density of water. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Change From Baseline in Urinalysis by Visit - pH Level

  A small volume of urine was collected and sent to a laboratory for analysis. The pH scale ranges from 0 (most acidic) to 14 (most alkaline), with 7 as neutral. Minimal change from the start of the study indicates a better outcome.

  Baseline (Day 1 pretreatment), Day 180, Day 365

• Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit

  Visual acuity with correction in place (spectacles or a trial frame with lenses) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts (original or modified) at a distance of 10 feet. Each line on the ETDRS chart typically has five letters, and each letter correctly identified adds to the overall score. ETDRS letter scores range from 0 to 100, with each letter correctly identified representing a score of 1. A perfect score of 100 is achieved when all 70 letters on the chart are correctly identified. 85 letters correctly identified corresponds to normal distance eyesight.

  Baseline (Day 1 pretreatment), Day 365

• Mean Corrected Visual Acuity in LogMar by Visit

  Visual acuity with correction in place (spectacles or a trial frame with lenses) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts (original or modified) at a distance of 10 feet. Each line on the ETDRS chart typically has five letters, and each letter correctly identified adds to the overall score. The overall letter score was converted to Logarithmic minimum angle of resolution (LogMAR). LogMAR scores typically range from -0.3 to 1.0, where zero represents normal vision, negative values indicate better than normal vision, and positive values indicate poorer than normal vision.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema

  An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lid erythema (redness of the eyelid) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema

  An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lid edema (swelling of the eyelid) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia

  An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to conjunctiva hyperemia (increased amount of blood in the conjunctiva) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema

  An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to conjunctiva edema (swelling of the conjunctiva) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion

  An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cornea staining/erosion were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema

  An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cornea edema (swelling of the cornea) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells

  An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cells in the anterior chamber (the fluid-filled space located in the front of the eye between the cornea and the iris) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare

  An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to anterior chamber flare (a visible clouding of the the fluid-filled space located in the front of the eye between the cornea and the iris) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity

  An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lens opacity (a clouding of the eye's natural lens) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Mean Total Ocular Staining Score by Visit

  Total corneal (fluorescein) staining score ranges between 0 and 5. Total conjunctival staining score is collected as the sum of lissamine green staining nasal and temporal scores and ranges between 0 and 10 per eye. Total ocular staining score is collected as the sum of total corneal and conjunctival scores (0 to 15) with a maximum possible score of 15 per eye. A higher total score indicates greater staining (or worse condition).

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Mean Intraocular Pressure by Visit

  Intraocular pressure was measured using Goldmann applanation tonometry and measured in millimeters mercury (mmHg). Values between 10mmHg and 20mmHg are considered normal eye pressure.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous

  An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the vitreous (the clear gel that fills the space between the lens and the retina of the eyeball) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina

  An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the retina (the light-sensitive tissue lining the back of the eye that converts light into electrical signals the brain then interprets as images) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula

  An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the macula (the round area at the center of the retina that provides central vision) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve

  An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the optic nerve (the nerve that transmits visual information from the retina to the brain) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

• Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid

  An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the choroid (the layer of blood vessels and connective tissue between the white of the eye and retina) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.

  Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

Study Arms (2)

0.003% AR-15512

EXPERIMENTAL

0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 365 days

Drug: 0.003% AR-15512 ophthalmic solution

AR-15512 Vehicle

PLACEBO COMPARATOR

AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 365 days

Drug: AR-15512 vehicle ophthalmic solution

Interventions

0.003% AR-15512 ophthalmic solution DRUG

Active ingredients administered via topical ocular instillation

0.003% AR-15512

AR-15512 vehicle ophthalmic solution DRUG

Inactive ingredients administered via topical ocular instillation

AR-15512 Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous history of Dry Eye Disease (DED) within the previous 12 months of the Baseline visit.
• Have used or desired to use artificial tears for DED symptoms within 3 months prior to the Baseline visit.
• Corrected visual acuity as specified in the protocol at the Baseline visit.
• Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history, and vital signs (heart rate and blood pressure) at the Baseline visit.

You may not qualify if:

• History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety.
• Current evidence of other significant ophthalmic disease requiring topical medication (e.g. glaucoma, ocular hypertension) which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation.
• Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study.
• Use of medications as specified in the protocol.
• Use of lid heating therapy (i.e., LipiFlow®, iLUX®) or Meibomian gland probing/therapeutic expression within 6 months prior to the Baseline visit or anticipated during the study.

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (10)

Arizona Eye Center

Chandler, Arizona, 85225, United States

Location

Arizona Eye Institute

Sun City, Arizona, 85351, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

Macy Eye Center

Los Angeles, California, 90048, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Shultz Vision

Northridge, California, 91325, United States

Location

SightMD

Manhasset, New York, 11030, United States

Location

University Eye Specialists

Maryville, Tennessee, 37803, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Periman Eye Institute

Seattle, Washington, 98119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Scientific Advisor, Clinical Research and Development
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Scientific Advisor, CRD

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 9, 2022
• Study Start: November 1, 2022
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)