CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 108 enrolled
Drug / intervention
0.2% 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/NCT04075227
NCT04075227Phase 4Completed

A Randomized Clinical Trial: Comparison of the Efficacy of Topical 0.2% Loteprednol Etabonate and Topical 0.1% Dexamethasone in Impending Recurrent Pterygium

Wannisa Suphachearabhan·interventional·Posted Aug 30, 2019·Updated Sep 6, 2019

In Brief

A Phase 4 clinical trial evaluating 0.2% loteprednol etabonate and 0.1% dexamethasone for Recurrent Pterygium of Eye and Steroid-Induced Glaucoma. Completed, enrolled 108 participants.

Detailed Summary

The objective of this study was to evaluate the efficacy of topical 0.2% loteprednol etabonate, a 'soft steroid', compared with topical 0.1% dexamethasone, which is widely used in postoperative pterygium excision to prevent the recurrence of pterygium. If 0.2% loteprednol etabonate is non-inferior in efficacy compared with 0.1% dexamethasone, it may be used postoperatively in pterygium excision patients with the benefit of a low incidence of ocular hypertension or secondary glaucoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 30, 2019
Enrollment StartOct 16, 2015
Primary CompletionMar 2, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.8 years ago

Interventions

0.2% loteprednol etabonatedrug

Use topical 0.2% loteprednol etabonate eyedrop every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.

0.1% dexamethasonedrug

Use topical 0.1% dexamethasone eyedrop every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.