Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing

Epithelial Defect After Phototherapeutic Keratectomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724892
• Other study ID #: othana001
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2012
• Last updated: March 14, 2014
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epithelial Defect After Phototherapeutic Keratectomy

Intervention

Drug:
• Dexamethasone

• Loteprednol etabonate

Locations

Country	Name	City	State
Thailand	Onsiri Thanathanee	Khon Kaen
Thailand	Srinagarind Hospital	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Amon M, Busin M. Loteprednol etabonate ophthalmic suspension 0.5 %: efficacy and safety for postoperative anti-inflammatory use. Int Ophthalmol. 2012 Oct;32(5):507-17. Epub 2012 Jun 16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	corneal epithelial healing		1 month	Yes
Secondary	intraocular pressure		6 month	Yes

External Links

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