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

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Surface Disease
• Intervention / Treatment: Drug: GL101; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • New York Eye & Ear Infirmary of Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GL101; GL101 topical gel	Drug: GL101; Topical Gel; Other Names: Pro-Ocular
Placebo Comparator: Placebo; Placebo topical gel	Drug: Placebo; Placebo topical gel

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events: Visual acuity; Slit lamp biomicroscopy; Undilated fundoscopy examination; Intraocular pressure	Day 1 to 4 weeks

Collaborators and Investigators

• Sponsor: Glia, LLC
• Investigators: Principal Investigator: Robert Ritch, MD, New York Eye & Ear Infirmary of Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2016
• Primary Completion (Actual): December 4, 2017
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: ocular surface disease; glaucoma medications
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: GL-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED