NCT03123614

Loteprednol vs. Prednisolone and Fluorometholone

Efficacy and Safety of Loteprednol 0.5% Gel for Routine Prophylaxis After Photorefractive Keratectomy Compared to Prednisolone Acetate 1% Suspension and Fluorometholone 0.1% Suspension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Intraocular Pressure
• Corneal Opacity

Interventions

Type	Name	Description
DRUG	Loteprednol Etabonate 0.5% Oph Gel
DRUG	Prednisolone Acetate 1% Oph Susp

Timeline

• Start date: 2014-09-19
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2017-04-21
• Last updated: 2021-05-26
• Results posted: 2020-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study