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Topical Gel
Pro-ocular™ Topical Gel 1% for Graft Versus Host Disease of the Eye
Phase 2 & 3
Waitlist Available
Research Sponsored by Glia, LLC
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 6 weeks, 12 weeks
Awards & highlights
Summary
This trial tests a special eye gel for patients with a specific eye condition who wear special contact lenses. The gel helps reduce eye discomfort and dryness, allowing them to wear their lenses comfortably for longer periods.
Eligible Conditions
- Graft Versus Host Disease (GVHD) of the Eye
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Modified Symptom Assessment in Dry Eye Questionnaire, Global Score for nighttime without scleral lenses.
Secondary study objectives
Change in Blurred or Cloudy Vision in Glia Ocular Surface Disease Symptoms Questionnaire.
Change in Central Corneal Staining
Other study objectives
Change in Conjunctival lissamine staining using NEI scoring.
Change in Conjunctival redness using Efron scale with 0.5 steps (with and without scleral lenses).
Change in Corneal fluorescein staining using modified NEI scoring.
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pro-ocular™ Topical Gel 1%Experimental Treatment1 Intervention
Group II: VehiclePlacebo Group1 Intervention
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Who is running the clinical trial?
Glia, LLCLead Sponsor
4 Previous Clinical Trials
192 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have certain eye conditions like facial herpes or nerve inflammation in your face, which may affect your eligibility for the study.You wear any type of lenses overnight, like scleral lenses or bandage contact lenses.You are not willing to stop using sunscreen on your forehead or around your eyes.You or someone in your immediate family (like your parents, siblings, or children) has had breast cancer in the past.You have had a bad reaction or are sensitive to the study drug.You have used or are currently using Pro-ocular™.If you wear special contact lenses called scleral lenses, and you feel the need to remove them at least once a day because they cause discomfort or make your vision blurry or cloudy, you will not be able to participate in the study.You have had certain eye infections or conditions in the past 5 years that have not been treated with medicine. If you have had a different type of herpes virus infection, you need to be taking the right medicine for it.You are currently using more than one eye drop for glaucoma that contains preservatives.You are currently participating in a study for an experimental treatment specifically for ocular GvHD.You have been diagnosed with ocular GvHD (a condition that affects the eyes) for at least 3 months before the start of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Vehicle
- Group 2: Pro-ocular™ Topical Gel 1%
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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