Loteprednol vs. Prednisolone and Fluorometholone
Primary Purpose
Intraocular Pressure, Corneal Opacity
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Loteprednol Etabonate 0.5% Oph Gel
Prednisolone Acetate 1% Oph Susp
Sponsored by
About this trial
This is an interventional treatment trial for Intraocular Pressure focused on measuring Photorefractive keratectomy
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.
Sites / Locations
- Moran Eye Center - Midvalley Location
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Loteprednol Etabonate 0.5% Oph Gel
Prednisolone acetate 1% Oph Susp
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Intraocular Pressure (IOP) From Baseline Through Month 3
Intraocular pressure will be measured by applanation tonometry
Secondary Outcome Measures
Number of Eyes With Corneal Haze
As determined by slit lamp examination
Uncorrected Visual Acuity
Best uncorrected visual acuity will be measured at 3 months
Best Corrected Visual Acuity at 3 Months
Best uncorrected visual acuity will be measured at 3 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03123614
Brief Title
Loteprednol vs. Prednisolone and Fluorometholone
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2014 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure, Corneal Opacity
Keywords
Photorefractive keratectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Examiners are masked to the treatment arm when obtaining measurements of intraocular pressure (IOP) and grading corneal haze.
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loteprednol Etabonate 0.5% Oph Gel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Prednisolone acetate 1% Oph Susp
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Loteprednol Etabonate 0.5% Oph Gel
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate 1% Oph Susp
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure (IOP) From Baseline Through Month 3
Description
Intraocular pressure will be measured by applanation tonometry
Time Frame
Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op
Secondary Outcome Measure Information:
Title
Number of Eyes With Corneal Haze
Description
As determined by slit lamp examination
Time Frame
12 months
Title
Uncorrected Visual Acuity
Description
Best uncorrected visual acuity will be measured at 3 months
Time Frame
3 months
Title
Best Corrected Visual Acuity at 3 Months
Description
Best uncorrected visual acuity will be measured at 3 months
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Mifflin, MD
Organizational Affiliation
University of Utah Moran Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moran Eye Center - Midvalley Location
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Loteprednol vs. Prednisolone and Fluorometholone
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