At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 33 enrolled
Drug / intervention
Pro-ocular™ topical gel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment Safety and Efficacy Using Pro-ocular™ 1% for Chronic Ocular Graft-versus-host Disease (GvHD) Following Allogeneic Hematopoietic Stem Cell Transplantation.
In Brief
A Phase 2 clinical trial evaluating Pro-ocular™ topical gel and Placebo topical gel for Chronic Ocular Graft-versus-host Disease. Completed, enrolled 33 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Ocular Graft-versus-host Disease
CountriesUnited States
CollaboratorsORA, Inc.
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartOct 2019
Primary CompletionOct 2021
Study CompletionNov 2021
TodayJul 2026
First PostedJun 18, 2019
Enrollment StartOct 17, 2019
Primary CompletionOct 31, 2021
Study CompletionNov 19, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.0 years ago
Interventions
Pro-ocular™ topical geldrug
Topical gel for forehead dermal application
Placebo topical geldrug
Topical gel for forehead dermal application