The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye
Dry Eye
About this trial
This is an interventional prevention trial for Dry Eye focused on measuring Dry Eye, Graft versus Host Disease, GVHD
Eligibility Criteria
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
Sites / Locations
- Massachusetts Eye and Ear Infirmary
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Cyclosporine A 0.05%
Artificial Tear
If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear) 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.
If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear) 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.