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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-22

Study Completion Date

2018-12-30

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.

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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.

Conditions

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Ocular Surface Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GL101

GL101 topical gel

Group Type ACTIVE_COMPARATOR

GL101

Intervention Type DRUG

Topical Gel

Placebo

Placebo topical gel

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo topical gel

Interventions

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GL101

Topical Gel

Intervention Type DRUG

Placebo

Placebo topical gel

Intervention Type DRUG

Other Intervention Names

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Pro-Ocular

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No