NCT04769648

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Glia, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Ocular Graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	Pro-ocular™ Topical Gel 1%	Pro-ocular™ is a topical gel applied dermally to forehead twice-daily
DRUG	Placebo	Placebo is a vehicle topical gel without active ingredient applied dermally to forehead twice-daily

Timeline

• Start date: 2021-04-15
• Primary completion: 2023-08-15
• Completion: 2023-10-15
• First posted: 2021-02-24
• Last updated: 2023-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study