At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 209 enrolled
Drug / intervention
OPC-12759 +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.
Confirmatory Study of OPC-12759 Ophthalmic Solution in Patients With Dry Eye
In Brief
A Phase 3 clinical trial evaluating OPC-12759 and Placebo for Dry Eye. Completed, enrolled 209 participants across 4 sites.
Detailed Summary
The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2012
First PostedAug 2012
Primary CompletionMar 2013
Study CompletionMay 2013
TodayJul 2026
First PostedAug 8, 2012
Enrollment StartAug 1, 2012
Primary CompletionMar 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.9 years ago
Interventions
OPC-12759drug
Instillation, 4 times/day for 4 weeks
Placebodrug