The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye
- Registration Number
- NCT00553735
- Lead Sponsor
- Massachusetts Eye and Ear Infirmary
- Brief Summary
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.
- Detailed Description
The purpose of this research study is to determine if early treatment using Restasis eye drops can prevent the development or delay the progression of dry eye syndrome in allogeneic bone marrow transplant (BMT) recipients.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cyclosporine A 0.05% Cyclosporine A 0.05% 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. Artificial Tear Arificial 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.
- Primary Outcome Measures
Name Time Method Corneal Staining Score 18 months Conjunctival Staining Score 18 Months Incidence and Severity of Ocular Adverse Event 18 Months Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
- Secondary Outcome Measures
Name Time Method Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire 18 Months Schirmer Without Anesthesia 18 Months Tear Break-up Time (TBUT) 18 Months Schirmer With Anesthesia 18 Months
Trial Locations
- Locations (1)
Massachusetts Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States