Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)

NCT ID: NCT01448213

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-01-31

Brief Summary

The purpose of this study is to compare two different commonly used steroid dosing regimens after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery. The investigators hope to determine if one is more effective at preventing rejection or if both are equally effective.

Detailed Description

Graft rejection is one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used after transplant surgery. The steroid eye drop dosing regimen varies from surgeon to surgeon, because no studies have been done to determine the optimum dosing regimen.

Conditions

Fuchs' Dystrophy; Bullous Keratopathy

Study Design

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

Study Groups

Fluorometholone 0.1% Solution

Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Group Type: ACTIVE_COMPARATOR

Fluorometholone

Intervention Type: DRUG

Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Prednisolone acetate 1% Solution

Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Group Type: ACTIVE_COMPARATOR

Prednisolone acetate

Intervention Type: DRUG

Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Interventions

Prednisolone acetate

Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Intervention Type: DRUG

Fluorometholone

Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female patient, at least 18 years of age, who is a candidate for DMEK due to corneal endothelial dysfunction or who has undergone DMEK within the last 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 entire one-year course of the study.
• Patient has best corrected visual acuity (BCVA) of at least 20/200 in the fellow eye.

Exclusion Criteria

• A patient with a previous failed graft in the study eye with a history of a prior rejection episode
• A patient exhibiting any 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
• A patient with the presence of any ocular disease that would interfere with the evaluation of the study treatment
• A patient with a history of non-compliance with using prescribed medication
• A patient who is concurrently involved in or participated in another clinical trial within 30 days prior to enrollment in this study.

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

Sponsors

Price Vision Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis W Price, MD

Role: PRINCIPAL_INVESTIGATOR

Price Vision Group

Friedrich Kruse, MD

Role: PRINCIPAL_INVESTIGATOR

University of Erlangen, Germany

Locations

Price Vision Group

Indianapolis, Indiana, United States

University of Erlangen

Erlangen, , Germany

Countries

United States; Germany

References

Price MO, Price FW Jr, Kruse FE, Bachmann BO, Tourtas T. Randomized comparison of topical prednisolone acetate 1% versus fluorometholone 0.1% in the first year after descemet membrane endothelial keratoplasty. Cornea. 2014 Sep;33(9):880-6. doi: 10.1097/ICO.0000000000000206.

Reference Type: RESULT

PMID: 25062336 (View on PubMed)

Related Links

http://www.pricevisiongroup.com

Price Vision Group Website

Other Identifiers

2011-0329

Identifier Type: -

Identifier Source: org_study_id