Loteprednol vs. Prednisolone and Fluorometholone

NCT ID: NCT03123614

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-19
• Study Completion Date: 2018-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Loteprednol Etabonate 0.5% Oph Gel

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Prednisolone Acetate 1% Oph Susp

Intervention Type: DRUG

Interventions

Loteprednol Etabonate 0.5% Oph Gel

Intervention Type: DRUG

Prednisolone Acetate 1% Oph Susp

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All subjects who are deemed suitable candidates for PRK after routine refractive surgery screening will be considered eligible for participation in this study.
• Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy).

Exclusion Criteria

• Selection will be consistent with the current standard of care for PRK. Any patient that is not a suitable candidate for PRK will not be included.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Mark Mifflin

Professor, Ophthalmology/Visual Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Mifflin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah Moran Eye Center

Locations

Moran Eye Center - Midvalley Location

Murray, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB # 75978

Identifier Type: -

Identifier Source: org_study_id