Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Epithelial Defect After Phototherapeutic Keratectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Loteprednol etabonate

Topical Loteprednol etabonate eye drop 0.5%, 4 times a day, 3 weeks

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone

Topical Dexamethasone eye drop 0.1%, 4 times a day, 3 weeks

Group Type ACTIVE_COMPARATOR

Loteprednol etabonate

Intervention Type DRUG

Interventions

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Dexamethasone

Intervention Type DRUG

Loteprednol etabonate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No