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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:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00553735
First received: November 2, 2007
Last updated: February 7, 2017
Last verified: April 2013
November 2, 2007
February 7, 2017
August 2007
December 2010   (Final data collection date for primary outcome measure)
  • 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.
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. [ Time Frame: 18 months ]
Complete list of historical versions of study NCT00553735 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Dry Eye
  • Drug: Cyclosporine A 0.05%
    Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.
    Other Name: Restasis
  • Drug: Arificial Tear
    Artificial Tear - three times a day for 18 months.
    Other Names:
    • Placebo
    • Artificial Tear
  • 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.

    Intervention: Drug: Cyclosporine A 0.05%
  • 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.

    Intervention: Drug: Arificial Tear
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00553735
07-05-034
07-05-034 ( Other Identifier: Massachusetts Eye and Ear )
No
Not Provided
Plan to Share IPD: No
Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
Not Provided
Principal Investigator: Reza Dana, M.D. Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP