The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Prophylactic Use of Topical Cyclosporine A 0.05% (Restasis) to Prevent Onset and Progression of Graft-versus-host Disease-related Dry Eye

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Cyclosporine A 0.05%
* Drug: Arificial Tear


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyclosporine A 0.05%<br>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. | Drug: Cyclosporine A 0.05%<br>* Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.<br>* Other names: Restasis;|
| Placebo Comparator: Artificial Tear<br>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. | Drug: Arificial Tear<br>* Artificial Tear - three times a day for 18 months.<br>* Other names: Artificial Tear;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining Score |  | 18 months | 
| Conjunctival Staining Score |  | 18 Months | 
| Incidence and Severity of Ocular Adverse Event | Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing. | 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire |  | 18 Months | 
| Tear Break-up Time (TBUT) |  | 18 Months | 
| Schirmer Without Anesthesia |  | 18 Months | 
| Schirmer With Anesthesia |  | 18 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GVHD, Dry Eye, Graft versus Host Disease