CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 514 enrolled
Drug / intervention
Loteprednol Etabonate Gel (BID) +3 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.

Search/NCT01996839
NCT01996839Phase 3Completed

Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Bausch & Lomb Incorporated·interventional·Posted Nov 27, 2013·Updated Sep 25, 2020

In Brief

A Phase 3 clinical trial evaluating Loteprednol Etabonate Gel (BID), Loteprednol Etabonate Gel (TID), and 2 other interventions for Inflammation and 2 related conditions. Completed, enrolled 514 participants across 1 site.

Detailed Summary

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 27, 2013
Enrollment StartDec 1, 2013
Primary CompletionMay 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.6 years ago

Interventions

Loteprednol Etabonate Gel (BID)drug

One drop of LE gel instilled into the study eye two times per day (BID) for 14 days

Loteprednol Etabonate Gel (TID)drug

One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.

Vehicle (BID)drug

One drop of vehicle instilled into the study eye two times per day (BID) for 14 days

Vehicle (TID)drug

One drop of vehicle instilled into the study eye three times per day (TID) for 14 days