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Phase 4 N=131 Randomized Single-blind Treatment

Loteprednol vs. Prednisolone and Fluorometholone

Intraocular Pressure · Corneal Opacity

Enrolled (actual)
131
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Change in Intraocular Pressure (IOP) From Baseline Through Month 3 — 14.38; 14.30; 13.67; 13.28 mmHg

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Loteprednol Etabonate 0.5% Oph Gel (Drug); Prednisolone Acetate 1% Oph Susp (Drug)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
University of Utah
Primary completion
Jul 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Intraocular Pressure (IOP) From Baseline Through Month 3
14.38; 14.30; 13.67; 13.28; 14.15; 14.60
SECONDARY
Number of Eyes With Corneal Haze
3; 7
SECONDARY
Uncorrected Visual Acuity
-0.078; -0.075
SECONDARY
Best Corrected Visual Acuity at 3 Months
-0.120; -0.114

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03123614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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