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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-12-31

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.

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cyclosporine A 0.05%

Intervention Type DRUG

Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.

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.

Group Type PLACEBO_COMPARATOR

Arificial Tear

Intervention Type DRUG

Artificial Tear - three times a day for 18 months.

Interventions

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Cyclosporine A 0.05%

Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.

Intervention Type DRUG

Arificial Tear

Artificial Tear - three times a day for 18 months.

Intervention Type DRUG

Other Intervention Names

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Restasis Placebo Artificial Tear

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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No