Skip to main content
OpenTrials
Completed

NCT Number: NCT06544707

A Study Designed to Evaluate Tear Production

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye Research Foundation

Newport Beach, California, 92663, United States

About this study

Qualified subjects will attend a single visit.

This is a Phase 3b, 2-stage study. In Stage 1, approximately 40 subjects will be enrolled, after which the study will be paused and an interim analysis will be conducted. Results from the Stage 1 analysis will help inform the design of Stage 2. An additional 40 subjects are planned for Stage 2.

For both stages, the primary endpoint and analysis will remain the same. Stage 2 will be tested independently with no pooling of data between stages.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.
  • Other protocol specified inclusion criteria may apply.

Key Exclusion Criteria:

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

Treatment and study plan

0.003% AR-15512 ophthalmic solution

Drug

Investigational ophthalmic solution administered via topical instillation

Other names: TRYPTYR®, Acoltremon ophthalmic solution 0.003%

Primary outcomes

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

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Phase 3b Open-Label Study Designed to Evaluate Tear Production Stimulated by 0.003% AR-15512

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.