A Study Designed to Evaluate Tear Production

NCT06544707 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DEF512-E002
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate tear production following acute administration of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) in subjects with dry eye disease (DED).

Conditions

Dry Eye Disease

Keywords

Dry Eyes; Eye Drops

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 1

  TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.

  Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation

• Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 2

  TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.

  Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation

Study Arms (1)

0.003% AR-15512

EXPERIMENTAL

One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours)

Drug: 0.003% AR-15512 ophthalmic solution

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

Eligibility Criteria

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

You may qualify if:

• Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported.
• Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms.
• Corrected visual acuity score of 20/200 or better in both eyes.
• Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history.

You may not qualify if:

• Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration).
• History of ocular surgery within 1 year of the Study Visit.
• Use of contact lenses in either eye within 7 days of the Study Visit.
• Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit.
• Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit.
• Used artificial tears within 2 hours of the Study Visit.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, 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

• 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: October 15, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)