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Lotoprednol vs. Prednisolone and Fluorometholone

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ClinicalTrials.gov Identifier: NCT03123614
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Mifflin, University of Utah

Brief Summary:

Corneal haze, in which the cornea becomes cloudy, is a well-known and a potentially vision-threatening postoperative complication of 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.


Condition or disease Intervention/treatment Phase
Intraocular Pressure Corneal Opacity Drug: Loteprednol Etabonate 0.5% Oph Gel Drug: Prednisolone Acetate 1% Oph Susp Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 19, 2014
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018


Arm Intervention/treatment
Active Comparator: Loteprednol Etabonate 0.5% Oph Gel
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
Active Comparator: Prednisolone acetate 1% Oph Susp
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



Primary Outcome Measures :
  1. Change in intraocular pressure from baseline through month 12 [ Time Frame: 12 months ]
    Intraocular pressure will be measured by applanation tonometry


Secondary Outcome Measures :
  1. Change in grade of corneal haze from month 1 through month 12 [ Time Frame: 12 months ]
    Corneal haze will be measured on the Fantes scale

  2. Change in manifest refraction from baseline through month 12 [ Time Frame: 12 months ]
    Manifest refraction will be measured

  3. Change in best corrected visual acuity from baseline through month 12 [ Time Frame: 12 months ]
    Best corrected visual acuity will be measured

  4. Change in uncorrected visual acuity from baseline through month 12 [ Time Frame: 12 months ]
    Best uncorrected visual acuity will be measured



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123614


Locations
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United States, Utah
Moran Eye Center - Midvalley Location
Murray, Utah, United States, 84107
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Mark Mifflin, MD University of Utah Moran Eye Center

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Responsible Party: Mark Mifflin, Professor, Ophthalmology/Visual Sciences, University of Utah
ClinicalTrials.gov Identifier: NCT03123614     History of Changes
Other Study ID Numbers: IRB # 75978
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018

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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

Keywords provided by Mark Mifflin, University of Utah:
Photorefractive keratectomy

Additional relevant MeSH terms:
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Eye Diseases
Corneal Opacity
Corneal Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Fluorometholone
Prednisolone hemisuccinate
Prednisolone phosphate
Loteprednol Etabonate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Allergic Agents