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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT01393132 (opens ClinicalTrials.gov in a new tab)Other id1003008179
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
9 participants (actual)
Sponsor
Michigan Cornea Consultants, PC · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Mar 2011
Primary completion
Dec 2012
Completion
Dec 2012
First posted
13 Jul 2011 (estimated)
Last update posted
23 Dec 2015 (estimated)
Conditions
Dry Eye · Sjogren's Syndrome · Graft vs. Host Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. Ph 2

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

    NCT01393132

    Mar 2011 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing. The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, 2010). The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface healing, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface. The investigators hope to be able to demonstrate an improvement in visual acuity, surface healing and a reduction in dry-eye related symptoms.

Interventions

  • Thymosin Beta 4 eye dropsDrug
  • Vehicle ControlDrug

Arms2

  • Experimental

    Thymosin Beta 4 eye drops

    It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days

  • Placebo comparator

    Vehicle Control

    It is composed of the same excipients as RGN-259 but does not contain Tβ4 for direct instillation into each eye, six times daily for 28 days.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Safety

    Time frame · Day 1, Day 14, Day 28 and Day 56

    Registry 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).

Secondary outcomes(3)

  1. Corneal Fluorescein Staining

    Time frame · Days 56 (+28 day follow up)

    Registry 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.

  2. Ocular Discomfort Index

    Time frame · Days 56 (+28 day follow up)

    Registry 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.

  3. Tear Film Break up Time

    Time frame · Days 56 (+28 day follow up)

    Registry 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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 1, Day 14, Day 28 and Day 56

Safety

GroupValue (event)
Thymosin0
Placebo0
Secondary and other outcome results(3)
Secondary outcomeMean· Days 56 (+28 day follow up)

Corneal Fluorescein Staining

GroupValue (units on a scale)Spread
Thymosin4.53.406
Placebo11.04.927
Secondary outcomeMean· Days 56 (+28 day follow up)

Ocular Discomfort Index

GroupValue (units on a scale)Spread
Thymosin45.62517.780
Placebo67.23315.658
Secondary outcomeMean· Days 56 (+28 day follow up)

Tear Film Break up Time

GroupValue (seconds)Spread
Thymosin5.5502.302
Placebo2.8481.137

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Thymosin Beta 4Thymosin 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.–0 / 60 / 6
Placebo: A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days–0 / 30 / 3

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

4 results

Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial.

Sosne et al. 2015Corneacited by 41

PMID 25826322DOI 10.1097/ico.0000000000000379PUB-25826322

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Schirmers of \< 5 mm at 5 minutes * TFBUT: less than 10 seconds * Corneal staining of \>3 of 15: conjunctival staining of \>3 of 18 * Ocular Surface Disease Index of \> 50 * Presumed best corrected vision of 20/60 or better Exclusion Criteria: * Acute or inflammatory corneal disease * Pregnancy or lactation * Monocular status * Punctal occlusion within 30 days * Ocular surgery within 3 months * Corneal thinning of \>50% * Active corneal infection * History of ocular malignancy * Retinal neovascularization * Current use of topical cyclosporin A

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