Phase 4
N=167
Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty
Fuchs' Dystrophy · Corneal Edema
Bottom Line
View on ClinicalTrials.gov: NCT01853696 ↗Enrolled (actual)
167
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Intraocular Pressure — 11; 27 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- loteprednol etabonate (Drug); prednisolone acetate 1% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cornea Research Foundation of America
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure |
11; 27 | — |
| SECONDARY Immunologic Graft Rejection Episode |
0; 0 | — |
Summary
Graft rejection has traditionally been one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used for an extended period after transplant surgery. The purpose of this study is to compare the efficacy and side effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea transplant) surgery.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Male or female patient who had endothelial keratoplasty procedure within the past 1 to 7 weeks
- Patient is able and willing to administer eye drops
- Patient is able to comprehend and has signed the Informed Consent form.
- Patient is likely to complete the one-year course of the study
Exclusion Criteria
- A history of a previous rejection episode in the study eye
- A patient exhibiting intraocular inflammation
- A patient with a known sensitivity to any of the ingredients in the study medications
- A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
- A patient with abnormal eyelid function.
- A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis.
- Presence of any ocular disease that would interfere with the evaluation of the study treatment. However, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled.
- A patient with a history of non-compliance with using prescribed medication.
- A patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study.
- Patients who are pregnant or planning to become pregnant within the duration of the study
Data sourced from ClinicalTrials.gov (NCT01853696). 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.