Ocular Surface DiseasePhase 2NCT02656394
Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101
A Phase 2 study testing GL101 in people with Ocular Surface Disease, run by Glia, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Surface Disease
- What is being tested?
- GL101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2016to 30 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Eye & Ear Infirmary of Mount Sinai
New York, New York, 10003
About this study
Official title: 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.
Read the 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.
- Conditions
- Ocular Surface Disease
- Being tested
- GL101, Placebo
- Keywords
- ocular surface disease, glaucoma medications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GL101Drug
Also called Pro-Ocular
Topical Gel
PlaceboDrug
Placebo topical gel
| Study group | Role | What they receive |
|---|---|---|
| GL101 | Active comparator | GL101 topical gel Receives: Drug: GL101 |
| Placebo | Placebo comparator | Placebo topical gel Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 to 4 weeks
Secondary outcomes (2)
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
Measured: Day 1 to 4 weeks
Other signs
Other signs:
- Visual acuity
- Intraocular pressure
- Artificial tear use
- Glaucoma medication compliance
Measured: Day 1 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start22 Jan 2016
- Primary completion4 Dec 2017
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glia, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Ritch, MD, Principal investigator, New York Eye & Ear Infirmary of Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656394
- Sponsor's protocol ID
- GL-1
- Status last verified
- Mar 2023
- First submitted
- 8 Jan 2016
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101 - Proof of Concept, Safety, and Efficacy Study
- ClinicalTrials.gov ID
- NCT02656394
- Acronym / sponsor ID
- GL-1
- Conditions
- Ocular Surface Disease
- Keywords
- ocular surface disease, glaucoma medications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Glia, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2016 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GL101 | Active comparator | Drug: GL101GL101 topical gel |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo topical gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GL101Also: Pro-OcularTopical Gel | Drug | GL101 |
| PlaceboPlacebo topical gel | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Glaucoma medication ocular side effect signs
Time frame: Day 1 to 4 weeks
Other signs
Time frame: Day 1 to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Ritch, MD principal investigator
New York Eye & Ear Infirmary of Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GL101 in people with Ocular Surface Disease, run by Glia, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glaucoma medication ocular side effect symptoms (time frame: Day 1 to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.