Trials / Completed
CompletedNCT05759208
The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease
A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of OK-101 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Okyo Pharma Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to compare the safety and efficacy of OK-101 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
Detailed description
Subjects eligible to be randomized will receive either OK-101 or placebo to be administered bilaterally twice daily (BID) for 12 weeks (from Visit 2 to Visit 5). During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally BID.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OK-101 | Ophthalmic Solution |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2023-04-28
- Primary completion
- 2023-12-15
- Completion
- 2023-12-15
- First posted
- 2023-03-08
- Last updated
- 2024-02-09
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05759208. Inclusion in this directory is not an endorsement.