Graft Versus Host Disease Related Dry Eye Clinical Trial
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.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts Eye and Ear Infirmary |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 18 months | No |