Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye

This study has been completed.
Sponsor:
Collaborator:
Kresge Eye Institute
Information provided by (Responsible Party):
Steven P. Dunn, M.D., Michigan Cornea Consultants, PC
ClinicalTrials.gov Identifier:
NCT01393132
First received: July 7, 2011
Last updated: December 21, 2015
Last verified: December 2015
Results First Received: December 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Dry Eye
Sjogren's Syndrome
Graft vs. Host Disease
Interventions: Drug: Thymosin Beta 4 eye drops
Drug: Vehicle Control

  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

Recruitment Details The study took place at Kresge Eye Institute by Dr. Gabriel Sosne, and at Michigan Cornea Consultants, P.C. by Dr. Steven P. Dunn,

The first subject was screened on Mar.2011 and the last subject last visit to the clinic was on Dec.2012


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Pre-assignment Details:

Subjects were evaluated upon entering the study after a two week washout period.


Reporting Groups
  Description
Thymosin

Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial

Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days.

Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.

Period Title * Participant Flow: Overall Study

Placebo Thymosin Beta 4 Started 3 6 Completed 3 6

Placebo

Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial

Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days.


Participant Flow:   Overall Study
    Thymosin     Placebo  
STARTED     6     3  
COMPLETED     6     3  
NOT COMPLETED     0     0  



  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
Thymosin

Comparison

Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.

Placebo

Comparison

Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.

Total Total of all reporting groups

Baseline Measures
    Thymosin     Placebo     Total  
Number of Participants  
[units: participants]
  6     3     9  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     2     7  
>=65 years     1     1     2  
Age  
[units: Years]
Mean (Standard Deviation)
  54.2  (11.6)     63.7  (6.65)     57.33  (11.18)  
Gender  
[units: participants]
     
Female     4     2     6  
Male     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     6     3     9  



  Outcome Measures
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1.  Primary:   Safety   [ Time Frame: Day 1, Day 14, Day 28 and Day 56 ]

2.  Secondary:   Corneal Fluorescein Staining   [ Time Frame: Days 56 (+28 day follow up) ]

3.  Secondary:   Ocular Discomfort Index   [ Time Frame: Days 56 (+28 day follow up) ]

4.  Secondary:   Tear Film Break up Time   [ Time Frame: Days 56 (+28 day follow up) ]


  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: Gabriel Sosne, MD
Organization: Wayne State Univeristy, Detroit, MI
phone: 248-594-6702
e-mail: gsosne@med.wayne.edu


No publications provided by Michigan Cornea Consultants, PC

Publications automatically indexed to this study:

Responsible Party: Steven P. Dunn, M.D., Michigan Cornea Consultants, PC
ClinicalTrials.gov Identifier: NCT01393132     History of Changes
Other Study ID Numbers: 1003008179
Study First Received: July 7, 2011
Results First Received: December 8, 2015
Last Updated: December 21, 2015
Health Authority: United States: Food and Drug Administration