A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease

NCT06544694 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DEF512-E003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).

Conditions

Dry Eye Disease

Keywords

Dry Eyes; Eye Drops

Outcome Measures

Primary Outcomes (1)

• Least Squares Mean Percentage Change From Baseline in Goblet Cell Density at Day 90 for 0.003% AR-15512

  Goblet cells are specialized epithelial cells that secrete mucins onto the ocular surface to help hydrate and lubricate the eye surface. Samples of conjunctiva were collected on filter papers based on a technique called impression cytology. The filter papers were then processed in a lab to measure the number of goblet cells (cells/mm2). The percent change in goblet cell density at Day 90 compared to Day 1 (Baseline) was calculated. A positive change value indicates an improvement. Only one eye (study eye) contributed data to the analysis. This outcome measure was pre-specified for 0.003% AR-15512 arm only.

  Day 1 pre-instillation (Baseline), Day 90 post instillation

Study Arms (2)

0.003% AR-15512

EXPERIMENTAL

One drop of 0.003% AR-15512 ophthalmic solution in each eye twice daily for 90 days (treatment period)

Drug: 0.003% AR-15512 ophthalmic solution

Artificial Tears

ACTIVE COMPARATOR

One drop of artificial tears in each eye twice daily for 90 days (treatment period)

Other: Artificial Tears

Interventions

0.003% AR-15512 ophthalmic solution DRUG

Investigational ophthalmic solution administered via topical instillation

Also known as: TRYPTYR®, Acoltremon ophthalmic solution 0.003%

0.003% AR-15512

Artificial Tears OTHER

Commercially available, preservative-free lubricant eye drops administered via topical instillation

Also known as: REFRESH® Classic

Artificial Tears

Eligibility Criteria

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

You may qualify if:

• Have a previous history of DED, clinician diagnosed or patient reported, within the previous 6 months prior to the Screening visit.
• Have used artificial tears for DED symptoms within 2 months prior to the Screening visit.
• Corrected visual acuity equal to or better than logarithm Minimum angle of reflection (logMar) +0.7 (Snellen equivalent equal to or better than 20/100), as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at both the Screening and Baseline visits.
• Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history.

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, 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), or other ophthalmic disease which the investigator believes may interfere with study findings or interpretation.
• History of ocular surgery within 1 year prior to the Screening visit; history of corneal transplant in one or both eyes.
• Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study.
• Regular use, as assessed by the investigator, of lid hygiene or heat masks within 14 days prior to the Screening visit or any planned use during the study.
• Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit or anticipated during the study.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Oculus Research

Garner, North Carolina, 27529, United States

Location

Wilmington Eye

Leland, North Carolina, 28451, United States

Location

CORE, Inc.

Shelby, North Carolina, 28150, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

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

• Clinical Trial Lead, Pharma

  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: August 6, 2024
• First Posted: August 9, 2024
• Study Start: October 8, 2024
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)