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NCT03123614 · ClinicalTrials.gov registry record · Phase 4
Loteprednol vs. Prednisolone and Fluorometholone
A Phase 4 study of Intraocular Pressure and Corneal Opacity, sponsored by University of Utah.
- Completed
- Registry status
- Phase 4
- Development phase
- 131
- Enrollment target
- 1
- Study location
NCT03123614 is a Phase 4 study of Intraocular Pressure and Corneal Opacity that has completed, run by University of Utah. The registered enrollment target is 131 participants, above the 74-participant average among 9 other Intraocular Pressure trials with a reported enrollment target (77% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03123614, a Phase 4 study of Intraocular Pressure and Corneal Opacity, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 131 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Prednisolone Acetate 1% Oph Susp
- DRUG Loteprednol Etabonate 0.5% Oph Gel
Study Locations (1)
Utah
- Moran Eye Center - Midvalley Location - Murray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2014-09-19 |
| Est. Completion | 2018-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03123614
The ClinicalTrials.gov registry entry for NCT03123614 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 74-participant average among 9 other Intraocular Pressure trials with a reported enrollment target (77% higher). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Intraocular Pressure appearing as the primary indexed condition, and to 2 interventions - of which Prednisolone Acetate 1% Oph Susp is the first listed.
NCT03123614 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT03123614 about?
NCT03123614 is a clinical study titled "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. Goa...
What is the current status of trial NCT03123614?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 131 participants. The study started on 2014-09-19. Estimated completion is 2018-07.
What conditions does trial NCT03123614 study?
This clinical trial studies the following conditions: Intraocular Pressure, Corneal Opacity.
What interventions are being tested in trial NCT03123614?
The interventions under investigation include: Prednisolone Acetate 1% Oph Susp (DRUG), Loteprednol Etabonate 0.5% Oph Gel (DRUG).
Who is sponsoring clinical trial NCT03123614?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03123614 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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