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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
Study Summary
This trial will evaluate an investigational drug's effect on symptoms of ocular Graft-versus-Host Disease and on hours of comfortable scleral lens wear.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Modified Symptom Assessment in Dry Eye Questionnaire, Global Score for nighttime without scleral lenses.
Secondary outcome measures
Change in Blurred or Cloudy Vision in Glia Ocular Surface Disease Symptoms Questionnaire.
Change in Central Corneal Staining
Other outcome measures
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.
+6 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers actively looking for more participants for this clinical trial?
"The clinical trial is not recruiting at this time, however this may change in the future. According to information found on clinicaltrials.gov, which was last updated on 8/17/2022, the study was originally posted on 4/15/2021. There are currently 167 other trials that are actively recruiting participants."
Answered by AI
What is the main focus of this research?
"The purpose of this 12-week study is to monitor changes in the Modified Symptom Assessment in Dry eye Questionnaire, Global Score for nighttime without scleral lenses. Additionally, researchers will also be looking at secondary outcomes like Change in Patient-reported blurred or cloudy vision while wearing scleral lenses using VAS and Change in Blurred or Cloudy Vision in Glia Ocular Surface Disease Symptoms Questionnaire."
Answered by AI
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