Pro-ocular Gel for Graft Versus Host Disease of the Eye

Overseen By Sponsor Glia LLC

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Glia, LLC

Must not be taking: Antivirals, Corticosteroids, Glaucoma meds

Disqualifiers: COVID-19, Herpes, Breast cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 36

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new topical gel, Pro-ocular™ 1%, for individuals with ocular Graft-versus-Host Disease (oGvHD) who wear scleral lenses daily. The goal is to determine if the gel can reduce discomfort and vision problems that often necessitate lens removal throughout the day. Participants must have had oGvHD for at least three months and experience daily discomfort or vision issues with their lenses. The trial compares the gel to a placebo (a substance with no therapeutic effect) to assess its true benefits. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in oGvHD care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you should not have significant changes in certain eye-related medications like corticosteroids, cyclosporine, or lifitegrast within 7 days before screening. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that Pro-ocular™ Topical Gel 1% is likely to be safe for humans?

Research has shown that Pro-ocular™ 1% gel is generally safe for patients. In a study on dry eye disease, participants who used the gel reported only minor side effects, suggesting its safety for eye use. Another study found the gel easy and convenient to use, indicating it is well-tolerated.

This treatment is in the later stages of clinical trials, which typically means there is already some evidence supporting its safety in humans. For those considering joining a trial, these findings suggest that Pro-ocular™ 1% gel is likely safe to use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ocular Graft-versus-Host Disease?

Unlike other treatments for ocular graft-versus-host disease, Pro-ocular™ Topical Gel 1% offers a targeted approach specifically designed for patients wearing scleral lenses. Most current treatments involve systemic immunosuppressants or corticosteroids that can have widespread effects. Pro-ocular™ stands out because it is applied directly to the eye, potentially reducing systemic side effects and increasing local efficacy. Researchers are excited because this gel could provide relief with fewer side effects, offering a more convenient and focused solution for these patients.

What evidence suggests that Pro-ocular™ Topical Gel 1% might be an effective treatment for ocular Graft-versus-Host Disease?

Studies have shown that Pro-ocular™ 1% topical gel, which participants in this trial may receive, can alleviate symptoms of eye problems caused by graft-versus-host disease. In one study, patients using a similar gel reported less eye discomfort and did not experience serious side effects. Research also suggests this gel may quickly relieve dry eye symptoms, common in these patients. The treatment involves applying a gel to ease symptoms like dryness and irritation. While more studies are underway, early results are promising for those with eye issues related to graft-versus-host disease. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Be able and willing to follow oral and written instructions provided in English, with or without assistance and participate in all assessments and visits

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

Has staining score in central corneal region of ≥ 2 out of 10 in either eye at Visit 1

Exclusion Criteria

You currently have certain eye conditions like facial herpes or nerve inflammation in your face, which may affect your eligibility for the study.

You wear any type of lenses overnight, like scleral lenses or bandage contact lenses.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pro-ocular™ 1% or placebo for 12 weeks, with crossover to active treatment for placebo group at week 12

24 weeks

In-clinic visits at weeks 0, 12, and 24; remote assessments at weeks 6 and 18

Open-label extension

Participants may opt into continuation of active treatment long-term

28 weeks

In-clinic visits at weeks 36 and 52

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Pro-ocular™ Topical Gel 1%

How Is the Trial Designed?

Group I: Pro-ocular™ Topical Gel 1% Experimental Treatment 1 Intervention

Group II: Vehicle Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Glia, LLC

Lead Sponsor

Trials

5

Recruited

240+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9905686/

Recent advances in ocular graft-versus-host disease - PMC Forehead application of 1% progesterone gel also improved ocular signs and symptoms without severe adverse events, potentially revealing a novel neuroaxis drug ...

2. astctjournal.org astctjournal.org/article/S2666-6367(21)00674-6/pdf

Efficacy and Safety of 1% Progesterone Gel to the ... The quality of life of affected patients is severely impaired, as poor functional vision and constant ocular discomfort are incompatible with an indepen- dent ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/48/NCT03520348/Prot_SAP_000.pdf

Phase I clinical study, to evaluate the safety and tolerability ... Goals: To evaluate the safety and tolerability of the ophthalmic gel PRO-167 manufactured by Sophia. Laboratories S.A. of C.V. on the ocular ...

4. trial.medpath.com trial.medpath.com/clinical-trial/6e4cfbee4480cbcd/nct04769648-safety-efficacy-pro-ocular-scleral-lens-graft-host-disease

Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens ... 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 ...

5. trial.medpath.com trial.medpath.com/clinical-trial/a22443557dba7fc4/nct04884217-treatment-dry-eye-disease-pro-ocular

Treatment of Dry Eye Disease Using Pro-ocular - MedPath Pro-ocular™ 1% topical gel his demonstrated efficacy in rapidly reducing or eliminating dry eye symptoms, and after multiple doses, the signs and symptoms ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04884217

Treatment of Dry Eye Disease Using Pro-ocular™ Study DE-2 is single center, randomized, double-masked, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of 1% Pro-ocular ...

7. signal12inc.com signal12inc.com/pro-ocular/

Pro-ocular Our Pro-ocular™ gel treats oGvHD symptoms by engaging the central nervous system to produce the body's own tear film. · Convenient and Tolerable · Ease of Use.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33942724/

Efficacy and Safety of 1% Progesterone Gel to the ... Forehead application of 1% progesterone gel significantly improved ocular signs and symptoms within 10 weeks. It appears to be a safe and effective new therapy ...