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OK-101 for Dry Eye Syndrome

Phase 2
Waitlist Available
Research Sponsored by Okyo Pharma Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 85 days
Awards & highlights

Summary

This trial tests a new eye drop to see if it's safe and effective for treating dry eye.

Who is the study for?
Adults over 18 with a history of dry eye for at least 6 months, who have used or want to use eye drops for dry eyes. They must meet certain criteria related to eye health and agree to not wear contacts during the trial. Women of childbearing age must test negative for pregnancy and use birth control.Check my eligibility
What is being tested?
The study is testing OK-101 Ophthalmic Solution against a placebo in treating signs and symptoms of dry eye disease. Participants will be randomly assigned to receive either the test medication or a placebo.See study design
What are the potential side effects?
Potential side effects are not detailed here, but as with any ophthalmic solution, there may be risks such as irritation, redness, discomfort, or allergic reactions specific to the components of OK-101.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~85 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ocular Discomfort Score
Total Corneal Fluorescein Staining
Secondary outcome measures
Conjunctival Redness
Fluorescein Staining by Region
Lissamine Green Staining by Region
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
OK-101 Placebo Ophthalmic Solution (vehicle): 1 drop BID in each eye (N = ~80)
Group II: Low Dose OK-101Experimental Treatment1 Intervention
0.05% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = ~80)
Group III: High-Dose OK-101Experimental Treatment1 Intervention
0.1% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = ~80)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OK-101
2023
Completed Phase 2
~240
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Okyo Pharma LtdLead Sponsor
ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,712 Total Patients Enrolled
Raj Patil, PhDStudy DirectorOkyo Pharma Ltd

Media Library

OK-101 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05759208 — Phase 2
Dry Eye Syndrome Research Study Groups: Placebo, Low Dose OK-101, High-Dose OK-101
Dry Eye Syndrome Clinical Trial 2023: OK-101 Highlights & Side Effects. Trial Name: NCT05759208 — Phase 2
OK-101 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05759208 — Phase 2
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