MedTrace Logo

Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium

NCT04075227 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-09-06

No results posted yet for this study

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.

Conditions

  • Recurrent Pterygium of Eye
  • Steroid-Induced Glaucoma

Interventions

DRUG

0.2% loteprednol etabonate

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.

DRUG

0.1% dexamethasone

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.

Sponsors & Collaborators

  • Srinakharinwirot University

    collaborator OTHER

  • Wannisa Suphachearabhan

    lead OTHER

Principal Investigators

  • Wannisa Suphachearabhan, MD · Srinakharinwirot University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-16
Primary Completion
2019-03-02
Completion
2019-03-02

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075227 on ClinicalTrials.gov