Loteprednol vs. Prednisolone and Fluorometholone

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intraocular Pressure, Corneal Opacity

Intervention / Treatment
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* Drug: Loteprednol Etabonate 0.5% Oph Gel
* Drug: Prednisolone Acetate 1% Oph Susp


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Loteprednol Etabonate 0.5% Oph Gel<br>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<br> <br> |
| Active Comparator: Prednisolone acetate 1% Oph Susp<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With Corneal Haze | As determined by slit lamp examination | 12 months | 
| Uncorrected Visual Acuity | Best uncorrected visual acuity will be measured at 3 months | 3 months | 
| Best Corrected Visual Acuity at 3 Months | Best uncorrected visual acuity will be measured at 3 months | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photorefractive keratectomy