Loteprednol vs. Prednisolone and Fluorometholone

NCT03123614 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB # 75978
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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

Keywords

Photorefractive keratectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Eyes With Corneal Haze

  12 months

• Uncorrected Visual Acuity

  3 months

• Best Corrected Visual Acuity at 3 Months

  3 months

Study Arms (2)

Loteprednol Etabonate 0.5% Oph Gel

ACTIVE COMPARATOR

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

Prednisolone acetate 1% Oph Susp

ACTIVE COMPARATOR

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

Interventions

Loteprednol Etabonate 0.5% Oph Gel DRUG

Loteprednol Etabonate 0.5% Oph Gel

Prednisolone Acetate 1% Oph Susp DRUG

Prednisolone acetate 1% Oph Susp

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Moran Eye Center - Midvalley Location

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Corneal Opacity

Interventions

Loteprednol Etabonate; prednisolone acetate

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Mark Mifflin, MD
• Organization: University of Utah Moran Eye Center

Mark.Mifflin@hsc.utah.edu

801-213-4152

Study Officials

• Mark Mifflin, MD

  University of Utah Moran Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Examiners are masked to the treatment arm when obtaining measurements of intraocular pressure (IOP) and grading corneal haze.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ophthalmology/Visual Sciences

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 21, 2017
• Study Start: September 19, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 26, 2021
• Results First Posted: December 21, 2020

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)