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

Ocular Surface Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656394
• Other study ID #: GL-1
• Status: Completed
• Phase: Phase 2
• Start date: January 22, 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: March 2023
• Source: Glia, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 30, 2018
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Ocular Surface Disease

Intervention

Drug:
• GL101
Topical Gel
• Placebo
Placebo topical gel

Locations

Country	Name	City	State
United States	New York Eye & Ear Infirmary of Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Glia, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse events: Visual acuity; Slit lamp biomicroscopy; Undilated fundoscopy examination; Intraocular pressure	Day 1 to 4 weeks
Primary	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	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
Secondary	Other signs	Other signs: Visual acuity; Intraocular pressure; Artificial tear use; Glaucoma medication compliance	Day 1 to 4 weeks