Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing
This study is currently recruiting participants.
Verified November 2012 by Khon Kaen University
Sponsor:
Khon Kaen University
Information provided by (Responsible Party):
Onsiri Thanathanee, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01724892
First received: November 6, 2012
Last updated: November 14, 2012
Last verified: November 2012
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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:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Loteprednol etabonate
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 32 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724892
Contacts
| Contact: Onsiri Thanathanee, MD | 66845146005 | onsirit@yahoo.com |
Locations
| Thailand | |
| Onsiri Thanathanee | Recruiting |
| Khon Kaen, Thailand, 40002 | |
| Contact: Onsiri Thanathanee, MD 66845146005 onsirit@yahoo.com | |
| Principal Investigator: Onsiri Thanathanee, MD | |
| Srinagarind Hospital | Recruiting |
| Khon Kaen, Thailand, 40002 | |
| Contact: Onsiri Thanathanee, MD 66845146005 onsirit@yahoo.com | |
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: | November 14, 2012 |
| 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 May 16, 2013