Loteprednol vs. Prednisolone and Fluorometholone

Phase 4

Completed

• Conditions: Intraocular Pressure; Corneal Opacity
• Interventions: Drug: Loteprednol Etabonate 0.5% Oph Gel; Drug: Prednisolone Acetate 1% Oph Susp

• Registration Number: NCT03123614
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-19
• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-21
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Results First Submitted: 2020-08-23
• Results First Submitted QC: 2020-11-24
• Results First Posted: 2020-12-21
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loteprednol Etabonate 0.5% Oph Gel	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.
Prednisolone acetate 1% Oph Susp	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.

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP) From Baseline Through Month 3	Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op	Intraocular pressure will be measured by applanation tonometry

Secondary Outcome Measures

Name	Time	Method
Number of Eyes With Corneal Haze	12 months	As determined by slit lamp examination
Uncorrected Visual Acuity	3 months	Best uncorrected visual acuity will be measured at 3 months
Best Corrected Visual Acuity at 3 Months	3 months	Best uncorrected visual acuity will be measured at 3 months

Trial Locations

Locations (1)

Moran Eye Center - Midvalley Location; 🇺🇸 Murray, Utah, United States