NCT06544707

A Study Designed to Evaluate Tear Production

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	0.003% AR-15512 ophthalmic solution	Investigational ophthalmic solution administered via topical instillation

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2024-08-09
• Last updated: 2026-02-10
• Results posted: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study