CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 107 enrolled
Drug / intervention
Loteprednol etabonate +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.

Search/NCT01475643
NCT01475643Phase 3Completed
CompareCT.gov

Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract

Bausch & Lomb Incorporated·interventional·Posted Nov 21, 2011·Updated Jun 11, 2019

In Brief

A Phase 3 clinical trial evaluating Loteprednol etabonate and Prednisolones acetate for Cataract. Completed, enrolled 107 participants across 1 site.

Detailed Summary

The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2011
Enrollment StartJun 1, 2013
Primary CompletionJun 2, 2017
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 14.6 years ago

Interventions

Loteprednol etabonatedrug

1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.

Prednisolones acetatedrug

1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.