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

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

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.

Study Overview

• Status: Terminated
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Cyclosporine A 0.05%; Drug: Arificial Tear

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Reza Dana, M.D., Massachusetts Eye and Ear Infirmary

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: November 2, 2007
• First Submitted That Met QC Criteria: November 5, 2007
• First Posted (Estimate): November 6, 2007

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Dry Eye; GVHD; Graft versus Host Disease
• Additional Relevant MeSH Terms: Immune System Diseases; Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Graft vs Host Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins; Lubricant Eye Drops
• Other Study ID Numbers: 07-05-034 (Other Identifier: Massachusetts Eye and Ear)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO