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OpenTrials
Completed

NCT Number: NCT03123614

Loteprednol vs. Prednisolone and Fluorometholone

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Moran Eye Center - Midvalley Location

Murray, Utah, 84107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Loteprednol Etabonate 0.5% Oph Gel

Drug

Prednisolone Acetate 1% Oph Susp

Drug

Primary outcomes

  1. Change in Intraocular Pressure (IOP) From Baseline Through Month 3

    Time frame: 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 outcomes

  1. Number of Eyes With Corneal Haze

    Time frame: 12 months

    As determined by slit lamp examination

  2. Uncorrected Visual Acuity

    Time frame: 3 months

    Best uncorrected visual acuity will be measured at 3 months

  3. Best Corrected Visual Acuity at 3 Months

    Time frame: 3 months

    Best uncorrected visual acuity will be measured at 3 months

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 21, 2017
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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