Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

NCT01853696 | Completed Phase 4 Results DMC

• 1 other identifier: 2013-0424
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure

  Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading.

  from 1 to 12 months after transplant

Secondary Outcomes (1)

• Immunologic Graft Rejection Episode

  within first year after cornea transplantation

Study Arms (2)

Loteprednol

ACTIVE COMPARATOR

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

Drug: loteprednol etabonate

Prednisolone acetate

ACTIVE COMPARATOR

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

Drug: prednisolone acetate 1%

Interventions

loteprednol etabonate DRUG

Also known as: Lotemax gel

Loteprednol

prednisolone acetate 1% DRUG

Prednisolone acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornea Research Foundation of America: lead

Study Sites (1)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Related Publications (1)

• 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.

  PMID: 26020827 DERIVED

MeSH Terms

Conditions

Corneal dystrophy, Fuchs' endothelial, 1; Corneal Edema

Interventions

Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Marianne Price, PhD
• Organization: Cornea Research Foundation of America

mprice@cornea.org

317-814-2990

Study Officials

• Francis W Price, Jr., MD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 15, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 15, 2015
• Results First Posted: April 30, 2015

Record last verified: 2015-04

Locations

US (1)