Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%

NCT ID: NCT01695668

Last Updated: 2015-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2015-02-28

Brief Summary

The purpose of this research is to:

1. Evaluate the safety and efficacy of a steroid eye drop (Lotemax) in patients who have been diagnosed with graft-versus-host disease (GVHD), which is a complication that may occur after bone marrow transplant where the newly transplanted material attacks the patient's body and may cause eye dryness.

2. Assess the safety and efficacy of Lotemax in decreasing the eye's reaction to the process in GVHD before the patient undergoes bone marrow transplant.

3. Compare how well Lotemax works in decreasing the process in GVHD with an immunosuppressive eye drop (Restasis), which has been commonly used in the treatment of this condition.

Detailed Description

Allogeneic bone marrow or peripheral stem cell transplantation result in Graft-versus-Host disease. Ocular symptoms may be the first presentation of GVHD and may be seen in the absence of systemic manifestations. GVHD is categorized into acute and chronic forms as defined by 100 days after the transplant. Acute GVHD is characterized by dermatitis, hepatitis, and enteritis. Chronic GVHD involves the skin, mouth, liver, gastrointestinal tract, lungs, and eyes. Ocular GVHD is a common cause of dry eye symptoms in patients who have undergone bone marrow transplant (BMT), and can be defined as ocular surface disease in the context of GVHD. Dry eyes develop in 76% of acute GVHD patients and between 62.5% and 81.8% of chronic GVHD patients. Current treatment for ocular GVHD includes topical cyclosporine 0.05% (Restasis, Allergan). Topical loteprednol etabonate 0.5% (Lotemax, Bausch and Lomb) has been shown to be safe and efficacious in treatment of inflammatory ocular disorders, but has not been prospectively studied in ocular GVHD.

2. Hypothesis: We anticipate that topical loteprednol etabonate 0.5% will be safe and efficacious in treatment of ocular GVHD patients, and would add to the armamentarium of therapeutics for this disease. Further, by following the natural progression of the disease prior to a patient's Bone Marrow Transplant (BMT), we may elucidate a new standard of care for these patients - one that involves referral to an ophthalmologist before ocular GVHD symptoms arise.

Conditions

Dry Eyes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lotemax

Loteprednol Etabonate 0.5%

Group Type: EXPERIMENTAL

Lotemax

Intervention Type: DRUG

Ophthalmic corticosteroid. It decreases inflammation of the eye

Restasis

Cyclosporine

Group Type: ACTIVE_COMPARATOR

Restasis

Intervention Type: DRUG

Restasis is an immunosuppressive agent. Cyclosporine may reduce inflammation in the eye.

Interventions

Lotemax

Ophthalmic corticosteroid. It decreases inflammation of the eye

Intervention Type: DRUG

Restasis

Restasis is an immunosuppressive agent. Cyclosporine may reduce inflammation in the eye.

Intervention Type: DRUG

Other Intervention Names

Loteprednol; cyclosporine

Eligibility Criteria

Inclusion Criteria

Scheduled for allogenic bone marrow transplant

Exclusion Criteria

Allergic reaction to loteprednol or cyclosporine, previous allogenic transplant

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

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Shahzad Mian

Terry J. Bergstrom Professor for Resident Education, Associate Professor, Cornea and External Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shahzad Mian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Other Identifiers

Lotemax_00045815

Identifier Type: -

Identifier Source: org_study_id