Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing

Khon Kaen University

Status and phase: Completed; Phase 4

Conditions: Epithelial Defect After Phototherapeutic Keratectomy

Treatments: Drug: Loteprednol etabonate; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01724892

othana001

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups

Loteprednol etabonate

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone

Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Loteprednol etabonate