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Completed

NCT Number: NCT02656394

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York Eye & Ear Infirmary of Mount Sinai

New York, 10003, United States

About this study

The study is to assess the safety and efficacy of a new treatment for ocular surface disease associated with the use of glaucoma medications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

GL101

Drug

Topical Gel

Other names: Pro-Ocular

Placebo

Drug

Placebo topical gel

Primary outcomes

  1. 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 outcomes

  1. 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
  2. Other signs

    Time frame: Day 1 to 4 weeks

    Other signs:

    • Visual acuity
    • Intraocular pressure
    • Artificial tear use
    • Glaucoma medication compliance

Other outcomes

  1. Adverse events

    Time frame: Day 1 to 4 weeks

    Adverse events:

    • Visual acuity
    • Slit lamp biomicroscopy
    • Undilated fundoscopy examination
    • Intraocular pressure

Sponsors and collaborators

Lead sponsor

Glia, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 15, 2016
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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