NCT07068958

A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: ORA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the safety and efficacy of 0.25% RCI001 Ophthalmic Solution twice a day (BID) and four times a day (QID) compared to placebo (vehicle) in the treatment of the signs and symptoms of dry eye. The secondary objective of this study is to evaluate the optimal dosing frequency of 0.25% RCI001 Ophthalmic Solution (BID versus QID) in the treatment of the signs and symptoms of dry eye.

Conditions

• Dry Eye Disease (DED)

Interventions

Type	Name	Description
DRUG	0.25% RCI001 Ophthalmic Solution	0.25% RCI001 Ophthalmic Solution
DRUG	Placebo Ophthalmic Solution (vehicle)	Placebo Ophthalmic Solution (vehicle)

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-07-16
• Last updated: 2025-07-16

Regulatory

• FDA-regulated drug study