NCT06544694

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	0.003% AR-15512 ophthalmic solution	Investigational ophthalmic solution administered via topical instillation
OTHER	Artificial Tears	Commercially available, preservative-free lubricant eye drops administered via topical instillation

Timeline

• Start date: 2024-10-08
• Primary completion: 2025-03-21
• Completion: 2025-03-21
• First posted: 2024-08-09
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study