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

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ClinicalTrials.gov Identifier: NCT01393132
Recruitment Status : Completed
First Posted : July 13, 2011
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Collaborator:
Kresge Eye Institute
Information provided by (Responsible Party):
Steven P. Dunn, M.D., Michigan Cornea Consultants, PC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Dry Eye
Sjogren's Syndrome
Graft vs. Host Disease
Interventions Drug: Thymosin Beta 4 eye drops
Drug: Vehicle Control
Enrollment 9
Recruitment Details

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

Pre-assignment Details:

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

Arm/Group Title Thymosin Placebo
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 6 3
Completed 6 3
Not Completed 0 0
Arm/Group Title Thymosin Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 6 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
2
  66.7%
7
  77.8%
>=65 years
1
  16.7%
1
  33.3%
2
  22.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 9 participants
54.2  (11.6) 63.7  (6.65) 57.33  (11.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants
Female
4
  66.7%
2
  66.7%
6
  66.7%
Male
2
  33.3%
1
  33.3%
3
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 3 participants 9 participants
6 3 9
1.Primary Outcome
Title Safety
Hide Description Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).
Time Frame Day 1, Day 14, Day 28 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymosin Placebo
Hide Arm/Group Description:
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.
Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
Overall Number of Participants Analyzed 6 3
Measure Type: Number
Unit of Measure: event
0 0
2.Secondary Outcome
Title Corneal Fluorescein Staining
Hide Description

Ocular surface irregularity as measured by Slit Lamp Examination (SLE) with fluorescein dye staining of the cornea at days 56 (+28 day follow up).

The scale used to determine the difference in corneal fluorescein staining is the Oxford scale. (The Oxford Scale measures corneal fluorescein staining) Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The five regions were summed, for a maximum score of 25. A higher score represents greater disability.

Time Frame Days 56 (+28 day follow up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymosin Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.5  (3.406) 11.0  (4.927)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thymosin, Placebo
Comments Comparison of fluorescein staining score between the placebo and Thymosin beta 4 groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0108
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Ocular Discomfort Index
Hide Description

Dry eye causes ocular discomfort, which is measured using a Ocular Surface Disease Index at 56 day (+28 day followup).

(Symptomatic improvement using the validated Ocular Surface Disease Index (OSDI).

The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision.

For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time.

OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4].

The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

Time Frame Days 56 (+28 day follow up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymosin Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
45.625  (17.780) 67.233  (15.658)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thymosin, Placebo
Comments Comparison of Ocular Discomfort Index score between the placebo and Thymosin beta 4 groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0141
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Tear Film Break up Time
Hide Description

Tear film break up time (TFBUT) was measured to evaluating the quality of tear at 56 day (+28 day follow up).

The tear film break-up time is defined as the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film.

Range : >10 seconds is thought to be normal, <5 seconds low (with high likelihood of dry eye symptoms).

Time Frame Days 56 (+28 day follow up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymosin Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: seconds
5.550  (2.302) 2.848  (1.137)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thymosin, Placebo
Comments Comparison of Tear Film Break up Time between the placebo and Thymosin beta 4 groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0162
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 56 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Thymosin Beta 4 Placebo
Hide Arm/Group Description 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. : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
All-Cause Mortality
Thymosin Beta 4 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Thymosin Beta 4 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Thymosin Beta 4 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/3 (0.00%) 
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
Responsible Party: Steven P. Dunn, M.D., Michigan Cornea Consultants, PC
ClinicalTrials.gov Identifier: NCT01393132     History of Changes
Other Study ID Numbers: 1003008179
First Submitted: July 7, 2011
First Posted: July 13, 2011
Results First Submitted: December 8, 2015
Results First Posted: December 23, 2015
Last Update Posted: December 23, 2015