At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 600 enrolled
Drug / intervention
Loteprednol Etabonate Ophthalmic Gel dosed TID +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 3, Multi-Center, Double-Masked, Vehicle-Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, (BID and TID) Versus Vehicle Gel
In Brief
A Phase 3 clinical trial evaluating Loteprednol Etabonate Ophthalmic Gel dosed TID, Loteprednol Etabonate Ophthalmic Gel dosed BID, and 1 other intervention for Cataract and 2 related conditions. Completed, enrolled 600 participants across 6 sites.
Detailed Summary
Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract, Pain, Ocular Inflammation
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartJun 2016
Primary CompletionJun 2017
Study CompletionJul 2017
TodayJul 2026
First PostedJun 1, 2016
Enrollment StartJun 1, 2016
Primary CompletionJun 13, 2017
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.1 years ago
Interventions
Loteprednol Etabonate Ophthalmic Gel dosed TIDdrug
Gel
Loteprednol Etabonate Ophthalmic Gel dosed BIDdrug
Gel
Vehicle Geldrug
Gel