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Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01724892
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Epithelial Defect After Phototherapeutic Keratectomy Drug: Dexamethasone Drug: Loteprednol etabonate Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2012
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. corneal epithelial healing [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. intraocular pressure [ Time Frame: 6 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724892


Locations
Thailand
Onsiri Thanathanee
Khon Kaen, Thailand, 40002
Srinagarind Hospital
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Onsiri Thanathanee, MD Khon Kaen University
More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Onsiri Thanathanee, othana, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01724892     History of Changes
Other Study ID Numbers: othana001
First Posted: November 12, 2012    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
BB 1101
Loteprednol Etabonate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents