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

Overview

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 Title of Study: “Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101 – Proof of Concept, Safety, and Efficacy Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 4, 2017

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.

Interventions

  • Drug: GL101
    • Topical Gel
  • Drug: Placebo
    • Placebo topical gel

Arms, Groups and Cohorts

  • Active Comparator: GL101
    • GL101 topical gel
  • Placebo Comparator: Placebo
    • Placebo topical gel

Clinical Trial Outcome Measures

Primary Measures

  • Glaucoma medication ocular side effect symptoms
    • Time Frame: Day 1 to 4 weeks
    • 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

Secondary Measures

  • Glaucoma medication ocular side effect signs
    • Time Frame: Day 1 to 4 weeks
    • 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
  • Other signs
    • Time Frame: Day 1 to 4 weeks
    • Other signs: Visual acuity Intraocular pressure Artificial tear use Glaucoma medication compliance

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Glia, LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert Ritch, MD, Principal Investigator, New York Eye & Ear Infirmary of Mount Sinai

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.