A Study Designed to Evaluate Tear Production

Phase 3

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: 0.003% AR-15512

• Registration Number: NCT06544707
• Lead Sponsor: Alcon Research

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).

Detailed Description

Qualified subjects will attend a single visit.

This is a Phase 3b. 2 stage study. In Phase 1, approximately 40 subjects will be enrolled, after which the study will be paused and an 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.

Study Timeline

• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Study Start: 2024-10-15
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.
• Have a corrected visual acuity score of 20/200 or better in both eyes.
• Have 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.
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.003% AR-15512	0.003% AR-15512	One drop in each eye in a staggered cadence (left eye followed by dosing of the right eye) approximately 2-4 hours apart

Primary Outcome Measures

Name	Time	Method
Change from baseline (pre-drop compared to 3 minutes post-drop) in tear meniscus height (TMH) as measured by optical coherence tomography (OCT) - Stage 1	Day 1, Minute 0 (pre-instillation); Day 1, Minute 3 (post-instillation) - Stage 1	TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) will be measured in millimeters using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A positive change value from baseline will indicate improvement. One eye (study eye) will be assessed.
Change from baseline (pre-drop compared to 3 minutes post-drop) in tear meniscus height (TMH) as measured by optical coherence tomography (OCT) - Stage 2	Day 1, Minute 0 (pre-instillation); Day 1, Minute 3 (post-instillation) - Stage 2	TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) will be measured in millimeters using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A positive change value from baseline will indicate improvement. One eye (study eye) will be assessed.

Trial Locations

Locations (1)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States