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

March 23, 2023 updated by: Glia, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York Eye & Ear Infirmary of Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 1 to 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Day 1 to 4 weeks
Other signs
Time Frame: Day 1 to 4 weeks

Other signs:

  • Visual acuity
  • Intraocular pressure
  • Artificial tear use
  • Glaucoma medication compliance
Day 1 to 4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Day 1 to 4 weeks

Adverse events:

  • Visual acuity
  • Slit lamp biomicroscopy
  • Undilated fundoscopy examination
  • Intraocular pressure
Day 1 to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glia, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Ritch, MD, New York Eye & Ear Infirmary of Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GL-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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