Clinical trial NCT02656394: Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101
Official title: Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101 - Proof of Concept, Safety, and Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Surface Disease
Keywords: ocular surface disease
glaucoma medications
Lead sponsor: Glia, LLC
Sponsor class: INDUSTRY
First posted: 2016-01-15
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glaucoma medication ocular side effect symptoms
timeFrame: Day 1 to 4 weeks
Secondary outcomes:
measure: Glaucoma medication ocular side effect signs
timeFrame: Day 1 to 4 weeks
measure: Other signs
timeFrame: Day 1 to 4 weeks
Other outcomes:
measure: Adverse events
timeFrame: Day 1 to 4 weeks
Locations:
city: New York
country: United States
facility: New York Eye & Ear Infirmary of Mount Sinai
state: New York
Study officials:
affiliation: New York Eye & Ear Infirmary of Mount Sinai
name: Robert Ritch, MD
role: PRINCIPAL_INVESTIGATOR
References: