Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Onsiri Thanathanee, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01724892
First received: November 6, 2012
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Epithelial Defect After Phototherapeutic Keratectomy
Drug: Dexamethasone
Drug: Loteprednol etabonate
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • corneal epithelial healing [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • intraocular pressure [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: November 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Onsiri Thanathanee, othana, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01724892     History of Changes
Other Study ID Numbers: othana001
Study First Received: November 6, 2012
Last Updated: March 14, 2014
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Loteprednol etabonate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
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

ClinicalTrials.gov processed this record on August 21, 2014