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

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ClinicalTrials.gov Identifier: NCT00553735
Recruitment Status : Terminated (High number of withdrawals, appt. no-shows, or those lost to follow-up.)
First Posted : November 6, 2007
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition: Dry Eye
Interventions: Drug: Cyclosporine A 0.05%
Drug: Arificial Tear

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Study Participants

Each eye of every participant was 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.

Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.


Participant Flow:   Overall Study
    All Study Participants
STARTED   8 
COMPLETED   1 
NOT COMPLETED   7 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
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.

Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.


Baseline Measures
   Arm I 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      7  87.5% 
>=65 years      1  12.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
 43  (17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  87.5% 
Male      1  12.5% 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures

1.  Primary:   Corneal Staining Score   [ Time Frame: 18 months ]

2.  Primary:   Conjunctival Staining Score   [ Time Frame: 18 Months ]

3.  Primary:   Incidence and Severity of Ocular Adverse Event   [ Time Frame: 18 Months ]

4.  Secondary:   Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire   [ Time Frame: 18 Months ]

5.  Secondary:   Tear Break-up Time (TBUT)   [ Time Frame: 18 Months ]

6.  Secondary:   Schirmer Without Anesthesia   [ Time Frame: 18 Months ]

7.  Secondary:   Schirmer With Anesthesia   [ Time Frame: 18 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
The study was terminated early due to a high number of patients who withdrew themselves, failed to show for their appointments, or were lost to follow-up.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Reza Dana, MD, MPH, MSc
Organization: Massachusetts Eye and Ear Infirmary
phone: 617-573-3313
e-mail: Cornea_Research@MEEI.Harvard.edu



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