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

Primary Purpose

Ocular Surface Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GL101
Placebo
Sponsored by
Glia, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Surface Disease focused on measuring ocular surface disease, glaucoma medications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York Eye & Ear Infirmary of Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

GL101

Placebo

Arm Description

GL101 topical gel

Placebo topical gel

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2016
Last Updated
March 23, 2023
Sponsor
Glia, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02656394
Brief Title
Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 22, 2016 (Actual)
Primary Completion Date
December 4, 2017 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glia, LLC

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Surface Disease
Keywords
ocular surface disease, glaucoma medications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GL101
Arm Type
Active Comparator
Arm Description
GL101 topical gel
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo topical gel
Intervention Type
Drug
Intervention Name(s)
GL101
Other Intervention Name(s)
Pro-Ocular
Intervention Description
Topical Gel
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo topical gel
Primary Outcome Measure Information:
Title
Glaucoma medication ocular side effect symptoms
Description
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
Time Frame
Day 1 to 4 weeks
Secondary Outcome Measure Information:
Title
Glaucoma medication ocular side effect signs
Description
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
Time Frame
Day 1 to 4 weeks
Title
Other signs
Description
Other signs: Visual acuity Intraocular pressure Artificial tear use Glaucoma medication compliance
Time Frame
Day 1 to 4 weeks
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Adverse events: Visual acuity Slit lamp biomicroscopy Undilated fundoscopy examination Intraocular pressure
Time Frame
Day 1 to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Ritch, MD
Organizational Affiliation
New York Eye & Ear Infirmary of Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Eye & Ear Infirmary of Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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