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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01695668
Recruitment Status : Completed
First Posted : September 28, 2012
Results First Posted : September 24, 2015
Last Update Posted : September 24, 2015
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Shahzad Mian, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Dry Eyes Drug: Lotemax Drug: Restasis Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol
Study Start Date : August 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: Lotemax
Loteprednol Etabonate 0.5%
Drug: Lotemax
Ophthalmic corticosteroid. It decreases inflammation of the eye
Other Name: Loteprednol

Active Comparator: Restasis
Drug: Restasis
Restasis is an immunosuppressive agent. Cyclosporine may reduce inflammation in the eye.
Other Name: cyclosporine

Primary Outcome Measures :
  1. Progression of Dry Eye Severity [ Time Frame: 1 year ]
    Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Scheduled for allogenic bone marrow transplant

Exclusion Criteria:

Allergic reaction to loteprednol or cyclosporine, previous allogenic transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01695668

Sponsors and Collaborators
University of Michigan
Bausch & Lomb Incorporated
Principal Investigator: Shahzad Mian, MD University of Michigan

Responsible Party: Shahzad Mian, Terry J. Bergstrom Professor for Resident Education, Associate Professor, Cornea and External Disease, University of Michigan Identifier: NCT01695668     History of Changes
Other Study ID Numbers: Lotemax_00045815
First Posted: September 28, 2012    Key Record Dates
Results First Posted: September 24, 2015
Last Update Posted: September 24, 2015
Last Verified: August 2015

Keywords provided by Shahzad Mian, University of Michigan:
Graft versus Host Disease (GVHD)
dry eyes
Bone marrow transplant (BMT)

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Loteprednol Etabonate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Allergic Agents