Loteprednol vs. Prednisolone and Fluorometholone

Intraocular Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123614
• Other study ID #: IRB # 75978
• Status: Completed
• Phase: Phase 4
• Start date: September 19, 2014
• Est. completion date: July 2018

Study information

• Verified date: May 2021
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Opacity
• Intraocular Pressure

Intervention

Drug:
• Loteprednol Etabonate 0.5% Oph Gel

• Prednisolone Acetate 1% Oph Susp

Locations

Country	Name	City	State
United States	Moran Eye Center - Midvalley Location	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intraocular Pressure (IOP) From Baseline Through Month 3	Intraocular pressure will be measured by applanation tonometry	Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op
Secondary	Number of Eyes With Corneal Haze	As determined by slit lamp examination	12 months
Secondary	Uncorrected Visual Acuity	Best uncorrected visual acuity will be measured at 3 months	3 months
Secondary	Best Corrected Visual Acuity at 3 Months	Best uncorrected visual acuity will be measured at 3 months	3 months