Phase 4
N=131
Loteprednol vs. Prednisolone and Fluorometholone
Intraocular Pressure · Corneal Opacity
Bottom Line
View on ClinicalTrials.gov: NCT03123614 ↗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
| Outcome | Result | p-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.
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.