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Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.

NCT03990051 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-05-06

Study results available
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Summary

To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.

Conditions

  • Chronic Ocular Graft-versus-host Disease

Interventions

DRUG

Pro-ocular™ topical gel

Topical gel for forehead dermal application

DRUG

Placebo topical gel

Topical gel for forehead dermal application

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Glia, LLC

    lead INDUSTRY

Principal Investigators

  • Zhonghui K Luo, MD, PhD · Massachusetts Eye and Ear, Longwood

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2021-10-31
Completion
2021-11-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03990051 on ClinicalTrials.gov