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NCT05759208 · ClinicalTrials.gov registry record · Phase 2
The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease
A Phase 2 study of Dry Eye Disease, sponsored by Okyo Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
- 6
- Study locations
NCT05759208: Completed Phase 2 study of Dry Eye Disease, sponsored by Okyo Pharma.
NCT05759208 is a Phase 2 study of Dry Eye Disease that has completed, run by Okyo Pharma. The registered enrollment target is 240 participants, roughly in line with the 248-participant average among 33 other Dry Eye Disease trials with a reported enrollment target. The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05759208, a Phase 2 study of Dry Eye Disease, has completed, sponsored by Okyo Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
Total corneal fluorescein staining score of the study eye using the Ora Calibra® scale, measured by mean change from baseline (Visit 2 pre-CAE®) to Day 85 (Visit 6). Each of the 5 areas will be scored on a scale of 0 to 4 for a total minimum score of 0 to total maximum score of 20, with 0 being best and 20 being worst.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OK-101
Study Locations (6)
California
- Eye Research Foundation - Newport Beach
Colorado
- Vision Institute - Colorado Springs
Kentucky
- Butchertown clinical Trials - Louisville
Massachusetts
- Andover Eye Associates - Andover
North Carolina
- Core Inc. - Shelby
Tennessee
- Total Eye Care, PA - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-04-28 |
| Est. Completion | 2023-12-15 |
| Phase | Phase 2 |
What the finished NCT05759208 record still lists
NCT05759208 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 248-participant average among 33 other Dry Eye Disease trials with a reported enrollment target.
The record links to 1 condition, with Dry Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05759208 lists 6 locations in 6 states (California, Colorado, Kentucky).
Frequently Asked Questions
What is clinical trial NCT05759208 about?
NCT05759208 is a clinical study titled "The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease". 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.
What is the current status of trial NCT05759208?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2023-04-28. Estimated completion is 2023-12-15.
What conditions does trial NCT05759208 study?
This clinical trial studies the following conditions: Dry Eye Disease.
What interventions are being tested in trial NCT05759208?
The interventions under investigation include: Placebo (DRUG), OK-101 (DRUG).
Who is sponsoring clinical trial NCT05759208?
This trial is sponsored by Okyo Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05759208 being conducted?
This trial has 6 study locations across California, Colorado, Kentucky, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05759208's enrollment target sits among peer trials
240 13th of 33 higher than 21 of 33 other Dry Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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-
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