Overview

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

Status:
Completed
Trial end date:
2019-03-02
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Wannisa Suphachearabhan
Collaborator:
Srinakharinwirot University
Treatments:
BB 1101
Dexamethasone
Dexamethasone acetate
Loteprednol Etabonate
Criteria
Inclusion Criteria:

- Patients who had pterygium excision with amniotic membrane transplantation and who had
impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading the
cornea

Exclusion Criteria:

- recurrent pterygium

- received adjunctive treatment with beta radiation, mitomycin C or 5-fluorouracil

- glaucoma or intraocular pressure > 21 mmHg

- history of 5-fluorouracil or chloramphenicol allergy