Clinical trial NCT00553735: The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Dry Eye
Keywords: Dry Eye
Graft versus Host Disease
GVHD
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Corneal Staining Score
timeFrame: 18 months
measure: Conjunctival Staining Score
timeFrame: 18 Months
measure: Incidence and Severity of Ocular Adverse Event
timeFrame: 18 Months
Secondary outcomes:
measure: Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire
timeFrame: 18 Months
measure: Tear Break-up Time (TBUT)
timeFrame: 18 Months
measure: Schirmer Without Anesthesia
timeFrame: 18 Months
measure: Schirmer With Anesthesia
timeFrame: 18 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Reza Dana, M.D.
role: PRINCIPAL_INVESTIGATOR
References: