Trial Outcomes & Findings for Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye (NCT NCT01393132)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Day 1, Day 14, Day 28 and Day 56

Results posted on

2015-12-23

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	6	3
Overall Study COMPLETED	6	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thymosin n=6 Participants 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 n=3 Participants 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 n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	54.2 Years STANDARD_DEVIATION 11.6 • n=5 Participants	63.7 Years STANDARD_DEVIATION 6.65 • n=7 Participants	57.33 Years STANDARD_DEVIATION 11.18 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, Day 14, Day 28 and Day 56

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).

Outcome measures

Outcome measures
Measure	Thymosin n=6 Participants 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 n=3 Participants Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
Safety	0 event	0 event

SECONDARY outcome

Timeframe: Days 56 (+28 day follow up)

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.

Outcome measures

Outcome measures
Measure	Thymosin n=6 Participants 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 n=3 Participants Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
Corneal Fluorescein Staining	4.5 units on a scale Standard Deviation 3.406	11.0 units on a scale Standard Deviation 4.927

SECONDARY outcome

Timeframe: Days 56 (+28 day follow up)

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.

Outcome measures

Outcome measures
Measure	Thymosin n=6 Participants 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 n=3 Participants Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
Ocular Discomfort Index	45.625 units on a scale Standard Deviation 17.780	67.233 units on a scale Standard Deviation 15.658

SECONDARY outcome

Timeframe: Days 56 (+28 day follow up)

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).

Outcome measures

Outcome measures
Measure	Thymosin n=6 Participants 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 n=3 Participants Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
Tear Film Break up Time	5.550 seconds Standard Deviation 2.302	2.848 seconds Standard Deviation 1.137

Adverse Events

Thymosin Beta 4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gabriel Sosne, MD

Wayne State Univeristy, Detroit, MI

Phone: 248-594-6702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place