At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 204 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.
A 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 in Patients With Keratoconjunctivitis Sicca
In Brief
A Phase 2 clinical trial evaluating R348 Ophthalmic Solution, 0.2%, R348 Ophthalmic Solution, 0.5%, and 1 other intervention for Keratoconjunctivitis Sicca. Completed, enrolled 204 participants across 20 sites.
Detailed Summary
The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratoconjunctivitis Sicca
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedJul 2013
Primary CompletionJul 2014
TodayJul 2026
First PostedJul 16, 2013
Enrollment StartJul 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.0 years ago
Interventions
R348 Ophthalmic Solution, 0.2%drug
R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
R348 Ophthalmic Solution, 0.5%drug
R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
Placebodrug
Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.