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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

Study 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Low Dose OK-101 been granted authorization by the FDA?

"Low Dose OK-101 is estimated to have a safety score of 2 due to the lack of evidence for efficacy, only limited data in support of its safety."

Answered by AI

How many participants are being sought for this research initiative?

"We seek to enroll 240 eligible patients at two primary sites: Butchertown Clinical Trials in Louisville, Kentucky and Total Eye Care, PA in Memphis, Tennessee."

Answered by AI

Is the research experiment accepting new participants presently?

"Affirmative. The data posted on clinicaltrials.gov confirm that this medical trial, first listed on April 28th 2023, is actively recruiting volunteers. A total of 240 subjects are sought from 3 separate clinics."

Answered by AI

What is the core purpose of this trial?

"According to the study's sponsor, ORA Inc., the primary outcome being measured over an 85 day period is Ocular Discomfort Score. Secondary outcomes include Conjunctival Redness (on a scale of 0-4), Schirmer’s Test and Fluorescein Staining by Region ( scored from 0-20)."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
Butchertown clinical Trials
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have tried other drugs that are very pricey and didn't seem to help.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease
2023. "The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05759208.
~125 spots leftby Apr 2025
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