A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye

NCT05201170 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: PL9643-301
• Study Type: interventional
• Target: 575
• Locations: 1 country
• Sites: 18

Brief Summary

This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an ophthalmic solution to determine if safe and efficacious for dry eye patients. After a 2-week run-in period, patients will be randomized equally to the PL9643 ophthalmic solution or vehicle ophthalmic solution administered bilaterally three times a day for 12 weeks. A Data Monitoring Committee was engaged to review interim data.

Conditions

Dry Eye; Dry Eye Syndromes

Keywords

Dry eye; Ophthalmology; Eye diseases; Corneal diseases; Conjunctival diseases; Ophthalmic Solutions; Pharmaceutical Solutions

Outcome Measures

Primary Outcomes (2)

• Conjunctival Sum Lissamine Green Staining

  Measured by the Ora Calibra® Scale. Change from Baseline to week 12.

  Visit 6 (Day 85), Change from Pre-CAE to Post-CAE

• Ocular Pain

  As Measured by Visual Analog Scale (VAS). PL9643 versus Vehicle, in hyper-responder sub-population. Hyper-responder sub-population is defined as those patients achieving a VAS score of 4 or greater within the first 30 minutes of being challenged in the CAE® (clinical symptom) at Visit 2.

  Change from Pre-CAE to Post-CAE at Visit 6 (Day 85)

Secondary Outcomes (10)

• Nasal Lissamine Green Staining in Study Eye

  Change from Baseline to Visit 6 (Day 85), Pre-CAE

• Tear Film Break-Up Time (TFBUT) in Study Eye

  Change from Baseline to Visit 6 (Day 85), Post-CAE

• Total Sum Lissamine Green Staining in Study Eye

  Change from Baseline Pre-CAE® to Week 12 Pre-CAE

• Ocular Pain for ITT

  Visit 6 (Day 85), Change from Pre-CAE to Post-CAE

• Inferior Fluorescein Staining in Study Eye

  Change from Baseline to Visit 6 (Day 85), Post-CAE

Other Outcomes (3)

• Pain for Hyper-Responders

  Change from Baseline to Visit 3 (Day 15), Post-CAE

• Pain for ITT

  Visit 3 (Day 15), Change from Pre-CAE to Post-CAE

• Eye Discomfort for Hyper-responders

  Visit 3 (Day 15), Change from Pre-CAE to Post-CAE

Study Arms (2)

PL9643 Ophthalmic Solution

EXPERIMENTAL

PL9643 ophthalmic solution bilaterally three times a day.

Drug: PL9643 Ophthalmic Solution

Vehicle Ophthalmic Solution

ACTIVE COMPARATOR

Vehicle ophthalmic solution bilaterally three times a day.

Drug: Vehicle Ophthalmic Solution

Interventions

Vehicle Ophthalmic Solution DRUG

Ophthalmic Solution

Also known as: Control

Vehicle Ophthalmic Solution

PL9643 Ophthalmic Solution DRUG

Ophthalmic Solution

Also known as: Active study medication

PL9643 Ophthalmic Solution

Eligibility Criteria

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

You may qualify if:

• Be at least 18 years of age;
• Provide written informed consent;
• Be willing and able to comply with all study procedures;
• Have a patient-reported history of dry eye for at least 5 years prior to Visit 1;
• Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
• Have a best corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1;
• Have an inferior fluorescein corneal staining score \> 1 at both Visits 1 and 2 Pre-CAE®;
• Have an Eye Discomfort from the Visual Analog Scale (VAS) ≥25 at both Visits 1 and 2 Pre-CAE®;
• Report a score of ≥ 2 according to the Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire in at least one of the dry eye symptoms at Visits 1 and 2 Pre-CAE®;
• Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2;
• Have a corneal fluorescein staining score of ≥ 2 in any corneal region (inferior, central or superior) according to the Ora Calibra® Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining in at least one eye at Visits 1 and 2 Pre-CAE®;
• Have a conjunctival redness score ≥ 1 according to the Ora Calibra® Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 Pre-CAE®;
• Demonstrate in the same eye(s) a response to the CAE®at Visits 1 and 2 as defined by:
• Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE® exposure;
• Reporting an Ocular Discomfort score ≥3 at 2 or more consecutive time points in at least one eye during CAE® exposure (if a subject has an Ocular Discomfort rating of 3 at time = 0 for an eye, s/he must report an Ocular Discomfort rating of 4 for two consecutive measurements for that eye). Note: a subject cannot have an Ocular Discomfort score of 4 at time = 0);

You may not qualify if:

• Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1 or Visit 2;
• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• Have used Restasis®, Xiidra®, Cequa®, or Eysuvis® within 60 days of Visit 1;
• Have had any ocular and/or lid surgeries in the past 6 months or have any planned ocular and/or lid surgeries over the study period;
• Have had any laser procedures (e.g. YAG capsulotomy) in the past 3 months;
• Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
• Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study); the respective wash-out periods are required for thefollowing medications:
• Ocular, oral or nasal antihistamines: 72 hours prior to Visit 1 and during the study.
• Oral aspirin or aspirin-containing products allowed if dose has been stable over past 30 days prior to Visit 1 and no change in dose is anticipated during the study period
• Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to Visit 1
• Any medication (oral or topical) known to cause ocular drying that has not been administered as a stable dose for at least 30 days prior to Visit 1 and during the study
• All other topical ophthalmic preparations (including artificial tear substitutes) other than the study drops: 72 hours prior to Visit 1
• Have an uncontrolled systemic disease;

Sponsors & Collaborators

• Palatin Technologies, Inc: lead

Study Sites (18)

Global Research Management

Glendale, California, 91204, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

East West Eye Institute

Torrance, California, 90505, United States

Location

Pankratz Eye Institute

Columbus, Indiana, 47203, United States

Location

Michael Washburn Center for Ophthalmic Research, LLC

Indianapolis, Indiana, 46240, United States

Location

Kentucky Eye Institute

Lexington, Kentucky, 40517, United States

Location

Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Center for Sight

Las Vegas, Nevada, 89052, United States

Location

Mint Hill

Mint Hill, North Carolina, 28227, United States

Location

Core, Inc

Shelby, North Carolina, 28150, United States

Location

Bergstrom Eye research, LLC

Fargo, North Dakota, 58103, United States

Location

Erie Retina Research, LLC

Erie, Pennsylvania, 16507, United States

Location

Advancing Vision Research

Goodlettsville, Tennessee, 37072, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research

Smyrna, Tennessee, 37167, United States

Location

Austin Clinical Research

Austin, Texas, 78750, United States

Location

Axis Clinical

Dallas, Texas, 75243, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Eye Diseases; Corneal Diseases; Conjunctival Diseases

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases

Study Officials

• Brian Dodge

  Palatin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All individuals involved in the conduct of the study, and the enrolled patients, will remain masked to the randomized study treatment assignments until the database is unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 1:1 to either the PL9643 treatment group or to the vehicle control group.

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: January 21, 2022
• Study Start: December 30, 2021
• Primary Completion: September 1, 2023
• Study Completion: November 21, 2023
• Last Updated: October 17, 2024

Record last verified: 2022-01

Locations

US (18)