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

Glia, LLC

Status and phase: Completed; Phase 2

Conditions: Ocular Surface Disease

Treatments: Drug: GL101; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02656394

GL-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

49 participants in 2 patient groups, including a placebo group

GL101

Active Comparator group

Description:

GL101 topical gel

Treatment:

Drug: GL101

Placebo

Placebo Comparator group

Description:

Placebo topical gel

Treatment:

Drug: Placebo