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Trial record 7 of 11 for:    thymosin beta 4

Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye

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.
 
ClinicalTrials.gov Identifier: NCT01387347
Recruitment Status : Completed
First Posted : July 4, 2011
Results First Posted : December 24, 2012
Last Update Posted : July 10, 2015
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
ReGenTree, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Dry Eye Syndrome
Dry Eye
Interventions Drug: Thymosin beta 4
Drug: Placebo
Enrollment 72
Recruitment Details The study took place at Ora Clinical Research and Development (a medical clinic)by Dr. Gail Torkildsen.The first subject was screened on 13 August 2011 and the last subject last visit to the clinic was on 20 September 2011.
Pre-assignment Details Subjects who initially qualified for study entry, had adequate baseline staining and redness and positive controlled adverse environment response, were instructed to discontinue all ophthalmic medications and instill a commercially-available sterile irrigating (balanced salt) solution (i.e., the run-in solution) twice a day until Visit 2, Day 0.
Arm/Group Title Placebo Thymosin Beta 4
Hide Arm/Group Description

The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.

Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.

RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4.

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

Period Title: Overall Study
Started 36 36
Completed 34 35
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Arm/Group Title Placebo Thymosin Beta 4 Total
Hide Arm/Group Description

The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.

Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.

RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4

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

Total of all reporting groups
Overall Number of Baseline Participants 36 36 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
  75.0%
27
  75.0%
54
  75.0%
>=65 years
9
  25.0%
9
  25.0%
18
  25.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 36 participants 72 participants
55.3  (12.76) 57.1  (12.07) 56.02  (12.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Female
25
  69.4%
29
  80.6%
54
  75.0%
Male
11
  30.6%
7
  19.4%
18
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants 36 participants 72 participants
36 36 72
1.Primary Outcome
Title Corneal Staining (Inferior Region) in the Worst Eye in the Controlled Adverse Environment (CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye
Hide Description

This is a test that uses orange dye (fluorescein) and a blue light to detect ocular surface defects associated with dry eye. If the test result is normal, the dye remains in the tear film on the surface of the eye and does not adhere to the eye itself. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29. The scale used to determine the difference in corneal fluorescein staining between RGN-259 and placebo is the ORA scale: 0= no staining (no detectable ocular defect)to 4= confluent staining( severe ocular defect).

Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes were equal at Visit 2, then the right eye was chosen as the worst eye.

Time Frame Day 29 (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population
Arm/Group Title Thymosin Beta 4 Placebo
Hide Arm/Group Description:
RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0% Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.08  (0.71) 1.9  (0.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thymosin Beta 4, Placebo
Comments Inferior corneal fluorescein staining score at Day 29(primary sign) was summarized using descriptive statistics (number of observations, mean, standard deviation, median, minimum, and maximum). Active treatment was compared to placebo using a two-sample t-test assuming unequal variances, assessed at the α = 0.05 level
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2596
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Thymosin Beta 4, Placebo
Comments Comparison of central corneal 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 0.0075
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Thymosin Beta 4, Placebo
Comments Comparison of superior corneal 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 0.0210
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Ocular Discomfort in the Worst Eye in the Controlled Adverse Environment(CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye.
Hide Description

Dry eye causes ocular discomfort, which is measured using a validated 4-point ORA Scale from the start of the dosing till the end of treatment (Day 29). 0 = no discomfort to 4 = constant discomfort.

If the measurement is lower, then improvement of ocular discomfort can be inferred. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29.

Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes had were equal at Visit 2, then the right eye was chosen as the worst eye.

Time Frame Day 29 (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT)
Arm/Group Title Placebo Thymosin Beta 4
Hide Arm/Group Description:

The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.

Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.

Thymosin beta 4 solution is a sterile eye drop solution containing 0.1%(w/w) Tβ4. Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
1.3  (1.1) 1.6  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Thymosin Beta 4
Comments Comparison between the groups uses a two-sample t-test assuming unequal variances, assessed at the alpha = 0.05 level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3734
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Thymosin Beta 4
Comments Comparison of discomfort score between the placebo and Thymosin beta 4 groups on Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0244
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Number of Adverse Events as a Measure of Safety and Tolerability
Hide Description The Adverse events, which will be followed, are: impairment of visual acuity, an increase in intraocular pressure (IOP), and an increase in corneal sensitivity in both eyes.
Time Frame Throughout the study till Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Placebo Thymosin Beta 4
Hide Arm/Group Description:
Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 (w/w) for direct instillation into each eye twice a day for 29 days.
RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye twice a day for 29 days.
Overall Number of Participants Analyzed 36 36
Measure Type: Number
Unit of Measure: Events
2 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Thymosin Beta 4
Hide Arm/Group Description

The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.

Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.

RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4

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

All-Cause Mortality
Placebo Thymosin Beta 4
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Thymosin Beta 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/36 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Thymosin Beta 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/36 (5.56%)      0/36 (0.00%)    
Eye disorders     
General disorder ocular and administration site conditions AND Instillation site pain, * 1 [1]  2/36 (5.56%)  4 0/36 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
[1]
stinging post administration study gtts (eye drops)
There were no limitations to trial RGN-DE-202 entitled:"Safety and Efficacy of Thymosin beta 4 Ophthalmic Solution in Patients with Dry Eye". All subjects were enrolled.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Won S. Yang, President & CEO
Organization: ReGenTree, LLC
Phone: 609-734-4328
EMail: wonsyang@regentreellc.com
Layout table for additonal information
Responsible Party: ReGenTree, LLC
ClinicalTrials.gov Identifier: NCT01387347     History of Changes
Other Study ID Numbers: RGN-DE-202
First Submitted: June 29, 2011
First Posted: July 4, 2011
Results First Submitted: November 29, 2012
Results First Posted: December 24, 2012
Last Update Posted: July 10, 2015