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

NCT02656394 | Completed Phase 2 DMC

• 1 other identifier: GL-1
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Surface Disease

Keywords

ocular surface disease; glaucoma medications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Glaucoma medication ocular side effect signs

  Day 1 to 4 weeks

• Other signs

  Day 1 to 4 weeks

Other Outcomes (1)

• Adverse events

  Day 1 to 4 weeks

Study Arms (2)

GL101

ACTIVE COMPARATOR

GL101 topical gel

Drug: GL101

Placebo

PLACEBO COMPARATOR

Placebo topical gel

Drug: Placebo

Interventions

GL101 DRUG

Topical Gel

Also known as: Pro-Ocular

GL101

Placebo DRUG

Placebo topical gel

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of any race, at least 18 years of age at Visit 1 Screening.
• Has provided verbal and written informed consent.
• Be able and willing to follow instructions, including participation in all study assessments and visits.
• Currently being treated for glaucoma using at least two medications, and be willing to continue on the same regime.
• 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.
• 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.

You may not qualify if:

• 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.
• Best corrected visual acuity (BCVA) at baseline \<20/200.
• Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study.
• A woman who is pregnant, nursing an infant, or planning a pregnancy.
• Has a known adverse reaction and/or sensitivity to the study drug or its components.
• Routine use (more than twice a week) of a chlorinated swimming pool.
• 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.
• Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.

Sponsors & Collaborators

• Glia, LLC: lead

Study Sites (1)

New York Eye & Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

Location

Study Officials

• Robert Ritch, MD

  New York Eye & Ear Infirmary of Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 15, 2016
• Study Start: January 22, 2016
• Primary Completion: December 4, 2017
• Study Completion: December 30, 2018
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

US (1)