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

A Phase 3b Study to Investigate the Effect of 0.003% AR-15512 on the Ocular Surface Characteristics of Subjects With Dry Eye Disease

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: 0.003% AR-15512 ophthalmic solution; Other: Artificial Tears

Detailed Description

Qualified subjects will enter a 14-day run-in period, followed by a 13-week randomized treatment period, for a total individual duration of participation of approximately 15 weeks. During the run-in period, subjects will administer Artificial Tears (REFRESH® Classic) as one drop in each eye twice daily.

This is a Phase 3b study.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Butchertown Clinical Trials
  • North Carolina
    • Garner, North Carolina, United States, 27529
      • Oculus Research
    • Leland, North Carolina, United States, 28451
      • Wilmington Eye
    • Shelby, North Carolina, United States, 28150
      • CORE, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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.
• Other protocol specified inclusion criteria may apply.

Key Exclusion Criteria:

• 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.
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.003% AR-15512; 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; Investigational ophthalmic solution administered via topical instillation; Other Names: TRYPTYR®; Acoltremon ophthalmic solution 0.003%
Active Comparator: Artificial Tears; One drop of artificial tears in each eye twice daily for 90 days (treatment period)	Other: Artificial Tears; Commercially available, preservative-free lubricant eye drops administered via topical instillation; Other Names: REFRESH® Classic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Pharma, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Actual): March 21, 2025
• Study Completion (Actual): March 21, 2025

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Eye Drops; Dry Eyes
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Ophthalmic Solutions; Pharmaceutical Solutions; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Solutions; Specialty Uses of Chemicals; Lubricants; Lubricant Eye Drops
• Other Study ID Numbers: DEF512-E003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No