Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of 0.5% GL101 topical gel administered twice daily for 28 days in ameliorating adverse ocular side effects in patients under ongoing treatment with glaucoma medications.

Detailed Description
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The study is to assess the safety and efficacy of a new treatment for ocular surface disease associated with the use of glaucoma medications.

Official Title
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Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101 - Proof of Concept, Safety, and Efficacy Study

Conditions
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Ocular Surface Disease

Intervention / Treatment
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* Drug: GL101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of any race, at least 18 years of age at Visit 1 Screening. Has provided verbal and written informed consent. Be able and willing to follow instructions, including participation in all study assessments and visits. Currently being treated for glaucoma using at least two medications, and be willing to continue on the same regime. Suffers from at least two of the symptoms in the GLIA™ Glaucoma Medication Ocular Side Effect Symptoms Questionnaire at a severity of 2 (moderate) or more. If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period. Exclusion Criteria: Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as corneal opacities and scars, dystrophies, epithelial scarring, infections, blood clots, etc. Best corrected visual acuity (BCVA) at baseline <20/200. Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study. A woman who is pregnant, nursing an infant, or planning a pregnancy. Has a known adverse reaction and/or sensitivity to the study drug or its components. Routine use (more than twice a week) of a chlorinated swimming pool. Unwilling or unable to cease using the following medications during the study period: Topical ocular cyclosporine (e.g. Restasis®), anti-histamines, antipsychotics, or eye gels. Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GL101<br>GL101 topical gel | Drug: GL101<br>* Topical Gel<br>* Other names: Pro-Ocular;|
| Placebo Comparator: Placebo<br>Placebo topical gel | Drug: Placebo<br>* Placebo topical gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glaucoma medication ocular side effect symptoms | Glaucoma medication ocular side effect symptoms: Ocular discomfort Burning Stinging Conjunctival redness Itching Dryness Foreign object sensation Grittiness Pain Eyelid swelling Eyelid redness Photophobia Excessive tearing Crusty lids Blurred vision | Day 1 to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glaucoma medication ocular side effect signs | Glaucoma medication ocular side effect signs: Tearscope tear film examination Tear meniscus height (TMH) Tear film break up time (NIKBUT) Bulbar redness (BR) Meibography Conjunctival redness (hyperemia) Blepharitis Lid margin vessel inflammation Punctate keratitis Corneal staining Conjunctival staining | Day 1 to 4 weeks | 
| Other signs | Other signs: Visual acuity Intraocular pressure Artificial tear use Glaucoma medication compliance | Day 1 to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular surface disease, glaucoma medications