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Metadata

Name
Loteprednol vs. Prednisolone and Fluorometholone
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT03123614
Description
Corneal haze, in which the cornea becomes cloudy, is a well-known and a potentially
vision-threatening postoperative complication of photorefractive keratectomy (PRK). Topical
ophthalmic corticosteroids are routinely prescribed by most surgeons postoperatively to help
prevent this complication.

Goals of topical steroids use after PRK include effective modulation of the healing response
to prevent corneal haze while at the same time minimizing side effects, such as intraocular
pressure elevation or cataract formation. Loteprednol etabonate is a corticosteroid that
exerts its therapeutic effects and is then quickly changed into inactive metabolites. This
relatively fast metabolism of loteprednol gives it a lower side effect profile than other
steroids, including a smaller effect on intraocular pressure. In the ophthalmic literature,
there is currently no consensus on a standard regimen or which type of corticosteroid should
be used after PRK.

Investigators are conducting a prospective, randomized trial to compare the incidence of
intraocular pressure rise and visually significant postoperative corneal haze after PRK with
the use of loteprednol 0.5% gel compared to the use of earlier generation steroids,
prednisolone acetate 1% suspension and fluorometholone 0.1% suspension.
Data or Study Types
clinical trial
Source Organization
Unknown
Access Conditions
available
Year
2017
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT03123614

Distributions

  • Encoding Format: HTML ; URL: https://clinicaltrials.gov/ct2/show/results/NCT03123614
This project was funded in part by grant U24AI117966 from the NIH National Institute of Allergy and Infectious Diseases as part of the Big Data to Knowledge program. We thank all members of the bioCADDIE community for their valuable input on the overall project.