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

NCT01695668 | Completed Results

• 1 other identifier: Lotemax_00045815
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research is to:

1. 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. 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. 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.

Conditions

Dry Eyes

Keywords

Graft versus Host Disease (GVHD); dry eyes; Bone marrow transplant (BMT); Restasis; Lotemax

Outcome Measures

Primary Outcomes (1)

• Progression of Dry Eye Severity

  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.

  1 year

Study Arms (2)

Lotemax

EXPERIMENTAL

Loteprednol Etabonate 0.5%

Drug: Lotemax

Restasis

ACTIVE COMPARATOR

Cyclosporine

Drug: Restasis

Interventions

Lotemax DRUG

Ophthalmic corticosteroid. It decreases inflammation of the eye

Also known as: Loteprednol

Lotemax

Restasis DRUG

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

Also known as: cyclosporine

Restasis

Eligibility Criteria

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

You may qualify if:

• Scheduled for allogenic bone marrow transplant

You may not qualify if:

• Allergic reaction to loteprednol or cyclosporine, previous allogenic transplant

Sponsors & Collaborators

• University of Michigan: lead
• Bausch & Lomb Incorporated: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes; Graft vs Host Disease

Interventions

Loteprednol Etabonate; Cyclosporins; Cyclosporine

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr Shahzad Mian
• Organization: University of Michigan

smian@med.umich.edu

734-647-8397

Study Officials

• Shahzad Mian, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Terry J. Bergstrom Professor for Resident Education, Associate Professor, Cornea and External Disease

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 28, 2012
• Study Start: August 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: February 1, 2015
• Last Updated: September 24, 2015
• Results First Posted: September 24, 2015

Record last verified: 2015-08