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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2016
End Date:September 2016
Contact:Luis Silva, MD
Email:cifgof.glaucoma@gmail.com
Phone:212-477-7540

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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

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.

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

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.
We found this trial at
1
site
New York, New York 10003
Principal Investigator: Robert Ritch, MD
Phone: 212-477-7540
?
mi
from
New York, NY
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