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Cyclosporine Eye Drops in Preventing Graft-Versus-Host Disease of the Eye in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer or Bone Marrow Failure Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755040
First Posted: September 18, 2008
Last Update Posted: March 7, 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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
Results First Submitted: October 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Interventions: Drug: cyclosporine ophthalmic emulsion
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm I

Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.

cyclosporine ophthalmic emulsion: Given as eye drops

Arm II

Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.

placebo: Given as eye drops


Participant Flow:   Overall Study
    Arm I   Arm II
STARTED   83   81 
COMPLETED   40   47 
NOT COMPLETED   43   34 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Ocular Cyclosporine (Restasis)

Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.

cyclosporine ophthalmic emulsion: Given as eye drops

Placebo

Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.

placebo: Given as eye drops

Total Total of all reporting groups

Baseline Measures
   Ocular Cyclosporine (Restasis)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 83   81   164 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      81  97.6%      75  92.6%      156  95.1% 
>=65 years      2   2.4%      6   7.4%      8   4.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (12.458)   49  (11.707)   49  (12.062) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      34  41.0%      39  48.1%      73  44.5% 
Male      49  59.0%      42  51.9%      91  55.5% 
Region of Enrollment 
[Units: Participants]
     
United States   83   81   164 


  Outcome Measures
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1.  Primary:   Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo)   [ Time Frame: Up to 2 years after transplantation ]

2.  Secondary:   Numerical Score of Ocular Surface Disease Index (OSDI) and Development or Lack of Ocular GVHD (by Ophthalmologic Examination) as Measured by Odds Ratio in a Linear Regression Model.   [ Time Frame: 1 year after transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Madan Jagasia, M.D.
Organization: Vanderbilt Ingram Cancer Center
phone: (615) 936-8422
e-mail: madan.jagasia@vanderbilt.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00755040     History of Changes
Other Study ID Numbers: VICC BMT 0766
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-BMT-0766
VU-080786
First Submitted: September 17, 2008
First Posted: September 18, 2008
Results First Submitted: October 14, 2016
Results First Posted: December 8, 2016
Last Update Posted: March 7, 2017