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

Phase 2

Completed

• Conditions: Ocular Surface Disease
• Interventions: Drug: GL101; Drug: Placebo

• Registration Number: NCT02656394
• Lead Sponsor: Glia, LLC

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-15
• Study Start: 2016-01-22
• Primary Completion: 2017-12-04
• Study Completion: 2018-12-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Male or female of any race, at least 18 years of age at Visit 1 Screening.
2. Has provided verbal and written informed consent.
3. Be able and willing to follow instructions, including participation in all study assessments and visits.
4. Currently being treated for glaucoma using at least two medications, and be willing to continue on the same regime.
5. 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.
6. 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

1. 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.
2. Best corrected visual acuity (BCVA) at baseline <20/200.
3. Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study.
4. A woman who is pregnant, nursing an infant, or planning a pregnancy.
5. Has a known adverse reaction and/or sensitivity to the study drug or its components.
6. Routine use (more than twice a week) of a chlorinated swimming pool.
7. 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.
8. Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GL101	GL101	GL101 topical gel
Placebo	Placebo	Placebo topical gel

Primary Outcome Measures

Name	Time	Method
Glaucoma medication ocular side effect symptoms	Day 1 to 4 weeks	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

Secondary Outcome Measures

Name	Time	Method
Glaucoma medication ocular side effect signs	Day 1 to 4 weeks	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
Other signs	Day 1 to 4 weeks	Other signs: * Visual acuity; * Intraocular pressure; * Artificial tear use; * Glaucoma medication compliance

Trial Locations

Locations (1)

New York Eye & Ear Infirmary of Mount Sinai; 🇺🇸 New York, New York, United States