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

Sponsor
Glia, LLC (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02656394
Collaborator
(none)
49
Enrollment
1
Location
2
Arms
47.2
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101 - Proof of Concept, Safety, and Efficacy Study
Actual Study Start Date :
Jan 22, 2016
Actual Primary Completion Date :
Dec 4, 2017
Anticipated Study Completion Date :
Dec 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: GL101

GL101 topical gel

Drug: GL101
Topical Gel
Other Names:
  • Pro-Ocular

    		•
    Placebo Comparator: Placebo

    Placebo topical gel

    Drug: Placebo
    Placebo topical gel

    Outcome Measures

    Primary Outcome Measures

    1. Glaucoma medication ocular side effect symptoms [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 Outcome Measures

    1. Glaucoma medication ocular side effect signs [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

    2. Other signs [Day 1 to 4 weeks]

      Other signs: Visual acuity Intraocular pressure Artificial tear use Glaucoma medication compliance

    Other Outcome Measures

    1. Adverse events [Day 1 to 4 weeks]

      Adverse events: Visual acuity Slit lamp biomicroscopy Undilated fundoscopy examination Intraocular pressure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York Eye & Ear Infirmary of Mount Sinai New York New York United States 10003

    Sponsors and Collaborators

    • Glia, LLC

    Investigators

    • Principal Investigator: Robert Ritch, MD, New York Eye & Ear Infirmary of Mount Sinai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Glia, LLC
    ClinicalTrials.gov Identifier:
    NCT02656394
    Other Study ID Numbers:
    • GL-1
    First Posted:
    Jan 15, 2016
    Last Update Posted:
    Jul 30, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Glia, LLC
    ocular surface disease
    glaucoma medications
    Additional relevant MeSH terms:
    Glaucoma

    Study Results

    No Results Posted as of Jul 30, 2019