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

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ClinicalTrials.gov Identifier: NCT02656394
Recruitment Status : Unknown
Verified January 2016 by GLIA LLC.
Recruitment status was:  Recruiting
First Posted : January 15, 2016
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
GLIA LLC

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
Ocular Surface Disease Drug: GL101 Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Study Start Date : January 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: GL101
GL101 topical gel
Drug: GL101
Topical Gel
Other Name: Pro-Ocular

Placebo Comparator: Placebo
Placebo topical gel
Drug: Placebo
Placebo topical gel




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Adverse events [ Time Frame: Day 1 to 4 weeks ]

    Adverse events:

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656394


Contacts
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Contact: Luis Silva, MD 212-477-7540 ext 5371 cifgof.glaucoma@gmail.com
Contact: Vanessa Alvarado 212-477-7540 ext 5371 vaeyeresearch@gmail.com

Locations
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United States, New York
New York Eye & Ear Infirmary of Mount Sinai Recruiting
New York, New York, United States, 10003
Contact: Luis Silva, MD    212-477-7540 ext 5371    cigof.glaucoma@gmail.com   
Contact: Vanessa Alvarado    212-477-7540 ext 5371    vaeyeresearch@gmail.com   
Principal Investigator: Robert Ritch, MD         
Sponsors and Collaborators
GLIA LLC
Investigators
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Principal Investigator: Robert Ritch, MD New York Eye & Ear Infirmary of Mount Sinai

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Responsible Party: GLIA LLC
ClinicalTrials.gov Identifier: NCT02656394     History of Changes
Other Study ID Numbers: GL-1
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by GLIA LLC:
ocular surface disease
glaucoma medications

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases