Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00553735
First received: November 2, 2007
Last updated: April 19, 2012
Last verified: April 2012

November 2, 2007
April 19, 2012
August 2007
December 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
Not Provided
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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Graft Versus Host Disease Related Dry Eye
Drug: Cyclosporine A 0.05%
Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.
Placebo Comparator: Arm I
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%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00553735
07-05-034, 07-05-034
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 2012

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