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

NCT04769648 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-03-24

No results posted yet for this study

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.

Conditions

  • Ocular Graft-versus-host Disease

Interventions

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

Sponsors & Collaborators

  • Glia, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2023-08-15
Completion
2023-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04769648 on ClinicalTrials.gov