Lotoprednol vs. Prednisolone and Fluorometholone
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|ClinicalTrials.gov Identifier: NCT03123614|
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : October 30, 2018
Corneal haze, in which the cornea becomes cloudy, is a well-known and a potentially vision-threatening postoperative complication of 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.
|Condition or disease||Intervention/treatment||Phase|
|Intraocular Pressure Corneal Opacity||Drug: Loteprednol Etabonate 0.5% Oph Gel Drug: Prednisolone Acetate 1% Oph Susp||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||September 19, 2014|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
Active Comparator: Loteprednol Etabonate 0.5% Oph Gel
Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response.
Drug: Loteprednol Etabonate 0.5% Oph Gel
Active Comparator: Prednisolone acetate 1% Oph Susp
Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response.
Drug: Prednisolone Acetate 1% Oph Susp
- Change in intraocular pressure from baseline through month 12 [ Time Frame: 12 months ]Intraocular pressure will be measured by applanation tonometry
- Change in grade of corneal haze from month 1 through month 12 [ Time Frame: 12 months ]Corneal haze will be measured on the Fantes scale
- Change in manifest refraction from baseline through month 12 [ Time Frame: 12 months ]Manifest refraction will be measured
- Change in best corrected visual acuity from baseline through month 12 [ Time Frame: 12 months ]Best corrected visual acuity will be measured
- Change in uncorrected visual acuity from baseline through month 12 [ Time Frame: 12 months ]Best uncorrected visual acuity will be measured
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123614
|United States, Utah|
|Moran Eye Center - Midvalley Location|
|Murray, Utah, United States, 84107|
|Principal Investigator:||Mark Mifflin, MD||University of Utah Moran Eye Center|