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

This study has been terminated.
(High number of withdrawals, appt. no-shows, or those lost to follow-up.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00553735
First Posted: November 6, 2007
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
  Purpose
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.

Condition Intervention Phase
Dry Eye Drug: Cyclosporine A 0.05% Drug: Arificial Tear Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Corneal Staining Score [ Time Frame: 18 months ]
  • Conjunctival Staining Score [ Time Frame: 18 Months ]
  • Incidence and Severity of Ocular Adverse Event [ Time Frame: 18 Months ]
    Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.


Secondary Outcome Measures:
  • Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire [ Time Frame: 18 Months ]
  • Tear Break-up Time (TBUT) [ Time Frame: 18 Months ]
  • Schirmer Without Anesthesia [ Time Frame: 18 Months ]
  • Schirmer With Anesthesia [ Time Frame: 18 Months ]

Enrollment: 8
Study Start Date: August 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553735


Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Reza Dana, M.D. Massachusetts Eye and Ear Infirmary
  More Information

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00553735     History of Changes
Other Study ID Numbers: 07-05-034
07-05-034 ( Other Identifier: Massachusetts Eye and Ear )
First Submitted: November 2, 2007
First Posted: November 6, 2007
Results First Submitted: October 2, 2012
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017
Last Verified: April 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Massachusetts Eye and Ear Infirmary:
Dry Eye
Graft versus Host Disease
GVHD

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Graft vs Host Disease
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Immune System Diseases
Cyclosporins
Cyclosporine
Lubricant Eye Drops
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Ophthalmic Solutions
Pharmaceutical Solutions