Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing
1 other identifier
interventional
32
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2012
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 6, 2012
CompletedFirst Posted
Study publicly available on registry
November 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedMarch 17, 2014
March 1, 2014
10 months
November 6, 2012
March 14, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
corneal epithelial healing
1 month
Secondary Outcomes (1)
intraocular pressure
6 month
Study Arms (2)
Loteprednol etabonate
ACTIVE COMPARATORTopical Loteprednol etabonate eye drop 0.5%, 4 times a day, 3 weeks
Dexamethasone
ACTIVE COMPARATORTopical Dexamethasone eye drop 0.1%, 4 times a day, 3 weeks
Interventions
Eligibility Criteria
You may qualify if:
- the patient with epithelial defect after phototherapeutic keratectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Onsiri Thanathanee
Khon Kaen, Changwat Khon Kaen, 40002, Thailand
Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, 40002, Thailand
Related Publications (2)
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. doi: 10.1007/s10792-012-9589-2. Epub 2012 Jun 16.
PMID: 22707339BACKGROUNDThanathanee O, Sriphon P, Anutarapongpan O, Athikulwongse R, Thongphiew P, Rangsin R, Suwan-apichon O. A randomized controlled trial comparing dexamethasone with loteprednol etabonate on postoperative photorefractive keratectomy. J Ocul Pharmacol Ther. 2015 Apr;31(3):165-8. doi: 10.1089/jop.2014.0107. Epub 2015 Jan 2.
PMID: 25555173DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Onsiri Thanathanee, MD
Khon Kaen University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- othana
Study Record Dates
First Submitted
November 6, 2012
First Posted
November 12, 2012
Study Start
November 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
March 17, 2014
Record last verified: 2014-03