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