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

Mass Eye and Ear

Status and phase: Terminated; Phase 4

Conditions: Dry Eye

Treatments: Drug: Arificial Tear; Drug: Cyclosporine A 0.05%

Study type: Interventional

Funder types: Other

Identifiers

NCT00553735

07-05-034 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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8 participants in 2 patient groups, including a placebo group

Cyclosporine A 0.05%

Active Comparator group

Description:

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.

Treatment:

Drug: Cyclosporine A 0.05%

Artificial Tear

Placebo Comparator group

Description:

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.

Treatment:

Drug: Arificial Tear