Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing

Phase 4

Completed

• Conditions: Epithelial Defect After Phototherapeutic Keratectomy
• Interventions: Drug: Dexamethasone; Drug: Loteprednol etabonate

• Registration Number: NCT01724892
• Lead Sponsor: Khon Kaen University

Brief Summary

Corticosteroid has been used for the treatment after phototherapeutic keratectomy (PRK). Dexamethasone, a potent steroid can retard the corneal epithelial healing rate and has numerous serious complications, especially glaucoma. Loteprednol, a new generation of corticosteroid has less potency than dexamethasone and was proposed to has less side effect regarding intraocular pressure (IOP) elevation. Therefore, Investigators would like to compare the effect of dexamethasone and loteprednol on corneal epithelial healing rate after PRK and risk of glaucoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-12
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• the patient with epithelial defect after phototherapeutic keratectomy

Exclusion Criteria

• the patient with systemic disease such as diabetes and connective tissue disease
• the patient with ocular surface disease such as dry eye and recurrent corneal erosion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loteprednol etabonate	Dexamethasone	Topical Loteprednol etabonate eye drop 0.5%, 4 times a day, 3 weeks
Dexamethasone	Loteprednol etabonate	Topical Dexamethasone eye drop 0.1%, 4 times a day, 3 weeks

Primary Outcome Measures

Name	Time	Method
corneal epithelial healing	1 month

Secondary Outcome Measures

Name	Time	Method
intraocular pressure	6 month

Trial Locations

Locations (2)

Onsiri Thanathanee; 🇹🇭 Khon Kaen, Thailand

Srinagarind Hospital; 🇹🇭 Khon Kaen, Thailand