Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease

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

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a special eye gel for patients with a specific eye condition who wear special contact lenses. The gel helps reduce eye discomfort and dryness, allowing them to wear their lenses comfortably for longer periods.

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.

Eligibility Criteria

Inclusion Criteria

Male or female of any race, at least 18 years of age at Visit 1

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

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

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

Treatment Details

Interventions

• Placebo
• Pro-ocular™ Topical Gel 1%

Participant Groups

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+