At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 enrolled
Drug / intervention
R348 Ophthalmic Solution, 0.2% +2 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.
Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions for the Treatment of Keratoconjunctivitis Sicca in Patients With Chronic Ocular Graft Versus Host Disease
In Brief
A Phase 2 clinical trial evaluating R348 Ophthalmic Solution, 0.2%, R348 Ophthalmic Solution, 0.5%, and 1 other intervention for Chronic Graft-versus-host Disease. Completed, enrolled 35 participants across 2 sites.
Detailed Summary
* To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures. * To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Graft-versus-host Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartMar 2014
Primary CompletionJul 2016
TodayJul 2026
First PostedJan 20, 2014
Enrollment StartMar 1, 2014
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.5 years ago
Interventions
R348 Ophthalmic Solution, 0.2%drug
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%drug
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
Placebo Ophthalmic Solutionother
Placebo Ophthalmic Solution 2 drops per eye twice a day