Official Title: “The Prophylactic Use of Topical Cyclosporine A 0.05% (Restasis) to Prevent Onset and Progression of Graft-Versus-Host Disease-Related Dry Eye”

The purpose of this study is to determine whether Restasis is an effective treatment for preventing the occurrence and progression of dry eye syndrome in patients who have recently received a bone marrow transplant and are at risk to graft-versus-host disease.

Study Type: Interventional

Study Design: Prevention, Double Blind (Subject, Investigator), Single Group Assignment

Study Primary Completion Date: February 2010

Intervention(s) in this Clinical Trial

• Drug: Cyclosporine A 0.05%
  • Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Arm I
  • The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.

Primary Measures

• The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
  • Time Frame: 18 months
    Safety Issue?: No

Inclusion Criteria:

• Male or female
• At least 18 years of age
• Approved candidate for allogeneic HSCT
• Ability to understand and provide informed consent to participate in this study
• Willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

• History of ocular or eyelid surgery
• History of glaucoma or ocular hypertension
• History of herpetic eye disease
• Patient with acne rosacea, blepharitis, or meibomitis, in the opinion of the investigator
• Any ocular disorder or condition (including ocular infection, trauma, and disease) that could possibly interfere with the interpretation of the study results
• Recent (3-month) history of wearing contact lens
• Anticipated contact lens wear during any portion of the study
• Recent (3-month) history of current use of topical steroids or antiglaucoma agents
• Any punctal occlusion within 2 months of the screening visit
• Significant sign or symptoms of dry eye (the definition of "dry eye" used for exclusion criteria is compatible with the recommendations of the NEI/Industry Workshop on Clinical Trials in Dry Eyes (Lemp, 1995) (see Appendix 1and 2)).
• History of connective tissue disease or diabetes.
• Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Massachusetts Eye and Ear Infirmary

Overall Clinical Trial Officials and Contacts

Reza Dana, M.D. Principal Investigator Massachusetts Eye and Ear Infirmary  

Overall Contact: Leila Smaga 617-573-4439 Leila_Smaga@meei.harvard.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00553735

Study ID Number: 07-05-034

ClinicalTrials.gov Identifier: NCT00553735

Health Authority: United States: Institutional Review Board