Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

NCT ID: NCT01853696

Last Updated: 2015-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-01-31

Brief 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.

Conditions

Fuchs' Dystrophy; Corneal Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Loteprednol

Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months

Group Type: ACTIVE_COMPARATOR

loteprednol etabonate

Intervention Type: DRUG

Prednisolone acetate

Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months

Group Type: ACTIVE_COMPARATOR

prednisolone acetate 1%

Intervention Type: DRUG

Interventions

loteprednol etabonate

Intervention Type: DRUG

prednisolone acetate 1%

Intervention Type: DRUG

Other Intervention Names

Lotemax gel

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cornea Research Foundation of America

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis W Price, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Price Vision Group

Locations

Price Vision Group

Indianapolis, Indiana, United States

Countries

United States

References

Price MO, Feng MT, Scanameo A, Price FW Jr. Loteprednol Etabonate 0.5% Gel Vs. Prednisolone Acetate 1% Solution After Descemet Membrane Endothelial Keratoplasty: Prospective Randomized Trial. Cornea. 2015 Aug;34(8):853-8. doi: 10.1097/ICO.0000000000000475.

Reference Type: DERIVED

PMID: 26020827 (View on PubMed)

Other Identifiers

2013-0424

Identifier Type: -

Identifier Source: org_study_id