Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing

March 14, 2014 updated by: Onsiri Thanathanee, Khon Kaen University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital
      • Khon Kaen, Thailand, 40002
        • Onsiri Thanathanee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Loteprednol etabonate
Topical Loteprednol etabonate eye drop 0.5%, 4 times a day, 3 weeks
Drug: Dexamethasone
ACTIVE_COMPARATOR: Dexamethasone
Topical Dexamethasone eye drop 0.1%, 4 times a day, 3 weeks
Drug: Loteprednol etabonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
corneal epithelial healing
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
intraocular pressure
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Onsiri Thanathanee, MD, Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (ESTIMATE)

November 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • othana001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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