Ocular Graft-versus-host DiseasePhase 2/3NCT04769648
Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease
A Phase 2/3 study testing Pro-ocular™ Topical Gel 1% in people with Ocular Graft-versus-host Disease, run by Glia, LLC at 1 site in United States.
Trial summary
This clinical study seeks to evaluate the safety and efficacy of Pro-ocular™1% topical gel in patients with ocular Graft-versus-Host Disease who wear scleral lenses daily. This vehicle-controlled trial will evaluate the investigational drug's effect on signs and symptoms of ocular Graft-versus-Host Disease and on the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Graft-versus-host Disease
- What is being tested?
- Pro-ocular™ Topical Gel 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 15 Oct 2023
- Phase
- Phase 2/3
- 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.
- Has had the diagnosis of ocular GvHD (oGvHD) for at least 3 months prior to Visit 1.
- Use of scleral lenses daily in both eyes for at least two months prior to Visit 1 for treatment of oGvHD with planned continuation for use of the same scleral lenses throughout this study.
- Excluding final scleral lens removal of the day, after successful daily insertion, patient feels need to remove or does remove one or both scleral lenses at least once per day due to physical discomfort or visual acuity issues (lenses have debris or deposit build up or vision is foggy, cloudy or blurry).
- Has staining score in central corneal region of ≥ 2 out of 10 in either eye at Visit 1.
- Has Modified SANDE Frequency score of ≥ 35 out of 100 in either eye for both Modified SANDE daytime questionnaire with lenses and Modified SANDE nighttime questionnaire without lenses.
Show all 10Show fewer
- Has provided verbal and written informed consent.
- Be able and willing to follow oral and written instructions provided in English, with or without assistance and participate in all assessments and visits.
- Has access to telephone necessary for evaluations.
- Had an ophthalmological exam within past year prior to Visit 1.
Who cannot join
- Has tested positive from COVID-19 within twenty-eight days prior to Screening.
- Active trigeminal neuritis, trigeminal neuralgia, ocular herpes zoster, facial herpes zoster, ocular herpes simplex, or neurotrophic keratitis at Visit 1.
- History of ocular herpes zoster, facial herpes zoster, ocular herpes simplex, or neurotrophic keratitis within the last 5 years that is not being medically managed including oral antivirals. Patients with a history of herpes simplex virus must be receiving appropriate antiviral therapy.
- History of breast cancer in patient or immediate biological family (parents, siblings and children).
- Eyelid surgery or ocular surgery within the last 12 weeks prior to screening that in the judgment of the clinical investigator will interfere with study assessments.
- Comorbidity with other severe, acute or chronic systemic or ocular condition that in the judgment of the investigator will interfere with study assessments, study participant safety, or study compliance such as active COVID-19 infection.
Show all 14Show fewer
- Significant change (e.g. discontinuation) in oral corticosteroid dose or corticosteroid-containing eye drops or gels, cyclosporine ophthalmic emulsion or lifitegrast ophthalmic solution within 7 days prior to screening.
- Wears any type of lenses overnight (e.g. scleral lenses, bandage contact lenses).
- Women of childbearing potential who are pregnant, nursing an infant, planning a pregnancy, not receiving an adequate method of birth control, or have a positive urine pregnancy test at Screening. Women of childbearing potential must be willing to use contraception throughout this study.
- Has a known adverse reaction and/or sensitivity to the study drug.
- Prior or current use of Pro-ocular™.
- Unwilling to cease the use of sunscreen on the forehead or eye area.
- Currently using more than one preserved topical medication for glaucoma.
- Currently enrolled in an investigational drug or device study exclusively for ocular GvHD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II/III Trial of Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease
This clinical study seeks to evaluate the safety and efficacy of Pro-ocular™1% topical gel in patients with ocular Graft-versus-Host Disease who wear scleral lenses daily. This vehicle-controlled trial will evaluate the investigational drug's effect on signs and symptoms of ocular Graft-versus-Host Disease and on the hours of daily comfortable and serviceable scleral lens wear.
Read the detailed description
This Phase 2/3 placebo-controlled clinical study of Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients with Ocular Graft-versus-Host Disease (oGvHD) will evaluate the the investigational drug's effect on signs and symptoms of oGvHD and subject-reported hours of duration of comfortable and serviceable scleral lens wear time.
The study will enroll 38 subjects. In the first 12 weeks, subjects will be randomized 1:1 active to placebo. At week 12, placebo subjects will cross-over to active drug treatment. At week 24, all subjects can opt into an open label phase.
In clinic visits will occur at weeks 0, 12 and 24 with remote telephone assessments at weeks 6 and 18. For subjects who opt into the open-label phase, in-clinic visits will occur at weeks 36 and 52.
Safety monitoring for adverse events will be performed at all onsite and remote visits.
- Conditions
- Ocular Graft-versus-host Disease
- Being tested
- Pro-ocular™ Topical Gel 1%, Placebo
- Keywords
- scleral lens, scleral lenses, scleral lens wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-ocular™ Topical Gel 1%Drug
Pro-ocular™ is a topical gel applied dermally to forehead twice-daily
PlaceboDrug
Placebo is a vehicle topical gel without active ingredient applied dermally to forehead twice-daily
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Not described Receives: Drug: Placebo |
| Pro-ocular™ Topical Gel 1% | Experimental | Not described Receives: Drug: Pro-ocular™ Topical Gel 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Symptom Assessment in Dry Eye Questionnaire, Global Score for nighttime without scleral lenses.
0-100 visual analog scale, lower score is a better outcome than a higher score
Measured: 12 weeks
Secondary outcomes (2)
Change in Central Corneal Staining
0-10 scale, lower score is a better outcome than a higher score
Measured: 12 weeks
Change in Blurred or Cloudy Vision in Glia Ocular Surface Disease Symptoms Questionnaire.
0-10 scale, lower score is a better outcome than a higher score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start15 Apr 2021
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Graft-versus-host 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 12 weeks randomized 1:1 active to placebo. At 12 weeks, placebo group crosses over to active drug. At week 24, all subjects can opt in to an open-label phase.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glia, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769648
- Sponsor's protocol ID
- oGvHD-2-SC
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
- A Phase II/III Trial of Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease
- ClinicalTrials.gov ID
- NCT04769648
- Acronym / sponsor ID
- oGvHD-2-SC
- Conditions
- Ocular Graft-versus-host Disease
- Keywords
- scleral lens, scleral lenses, scleral lens wear
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Glia, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 24 Feb 2021 (actual)
- 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.
This clinical study seeks to evaluate the safety and efficacy of Pro-ocular™1% topical gel in patients with ocular Graft-versus-Host Disease who wear scleral lenses daily. This vehicle-controlled trial will evaluate the investigational drug's effect on signs and symptoms of ocular Graft-versus-Host Disease and on the hours of daily comfortable and serviceable scleral lens wear.
Detailed description
This Phase 2/3 placebo-controlled clinical study of Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients with Ocular Graft-versus-Host Disease (oGvHD) will evaluate the the investigational drug's effect on signs and symptoms of oGvHD and subject-reported hours of duration of comfortable and serviceable scleral lens wear time.
The study will enroll 38 subjects. In the first 12 weeks, subjects will be randomized 1:1 active to placebo. At week 12, placebo subjects will cross-over to active drug treatment. At week 24, all subjects can opt into an open label phase.
In clinic visits will occur at weeks 0, 12 and 24 with remote telephone assessments at weeks 6 and 18. For subjects who opt into the open-label phase, in-clinic visits will occur at weeks 36 and 52.
Safety monitoring for adverse events will be performed at all onsite and remote visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 12 weeks randomized 1:1 active to placebo. At 12 weeks, placebo group crosses over to active drug. At week 24, all subjects can opt in to an open-label phase.
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: Placebo |
| Pro-ocular™ Topical Gel 1% | Experimental | Drug: Pro-ocular™ Topical Gel 1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female of any race, at least 18 years of age at Visit 1.
- Has had the diagnosis of ocular GvHD (oGvHD) for at least 3 months prior to Visit 1.
- Use of scleral lenses daily in both eyes for at least two months prior to Visit 1 for treatment of oGvHD with planned continuation for use of the same scleral lenses throughout this study.
- Excluding final scleral lens removal of the day, after successful daily insertion, patient feels need to remove or does remove one or both scleral lenses at least once per day due to physical discomfort or visual acuity issues (lenses have debris or deposit build up or vision is foggy, cloudy or blurry).
- Has staining score in central corneal region of ≥ 2 out of 10 in either eye at Visit 1.
Key exclusion criteria (14 listed)
- Has tested positive from COVID-19 within twenty-eight days prior to Screening.
- Active trigeminal neuritis, trigeminal neuralgia, ocular herpes zoster, facial herpes zoster, ocular herpes simplex, or neurotrophic keratitis at Visit 1.
- History of ocular herpes zoster, facial herpes zoster, ocular herpes simplex, or neurotrophic keratitis within the last 5 years that is not being medically managed including oral antivirals. Patients with a history of herpes simplex virus must be receiving appropriate antiviral therapy.
- History of breast cancer in patient or immediate biological family (parents, siblings and children).
- Eyelid surgery or ocular surgery within the last 12 weeks prior to screening that in the judgment of the clinical investigator will interfere with study assessments.
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 |
|---|---|---|
| Pro-ocular™ Topical Gel 1%Pro-ocular™ is a topical gel applied dermally to forehead twice-daily | Drug | Pro-ocular™ Topical Gel 1% |
| PlaceboPlacebo is a vehicle topical gel without active ingredient applied dermally to forehead twice-daily | Drug | Vehicle |
Primary outcome
Change in Modified Symptom Assessment in Dry Eye Questionnaire, Global Score for nighttime without scleral lenses.
Time frame: 12 weeks
0-100 visual analog scale, lower score is a better outcome than a higher score
2 secondary outcomes
Change in Central Corneal Staining
Time frame: 12 weeks
Change in Blurred or Cloudy Vision in Glia Ocular Surface Disease Symptoms Questionnaire.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Ocular Graft-versus-host Disease
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
RecruitingPhase 3
Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)
oGVHD, Ocular Graft Versus Host Disease
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 μG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
Ocular Graft Versus Host Disease
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pro-ocular™ Topical Gel 1% in people with Ocular Graft-versus-host 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 10 inclusion and 14 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: status not confirmed, 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in Modified Symptom Assessment in Dry Eye Questionnaire, Global Score for nighttime without scleral lenses. (time frame: 12 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.