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NCT01393132·Phase 2·INTERVENTIONAL

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

Thymosin Beta-4InflammationCompleted

Status

Completed

Phase

Phase 2

Enrollment

9

Locations

1

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Full detailed description

See above

Interventions

Treatment arms and agents.

DRUG

Thymosin Beta 4 eye drops

Patients will be randomized and will receive the same eye drops the Thymosin Beta 4.

DRUG

Vehicle Control

Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.

Timeline

From registration to results.

  1. First posted

    Jul 13, 2011

  2. Study start

    Mar 2011

  3. Primary completion

    Dec 2012

  4. Study completion

    Dec 2012

  5. Results posted

    Dec 23, 2015

  6. Registry updated

    Dec 23, 2015

Outcomes

What the study measures.

Primary outcomes

Safety

Time frame · 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).

Secondary outcomes

Corneal Fluorescein Staining

Time frame · 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.

Ocular Discomfort Index

Time frame · 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.

Tear Film Break up Time

Time frame · 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).

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
90 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Michigan Cornea Consultants, P.C.

Southfield, Michigan, United States

Publications

Results and literature.

PMID 25826322 ↗Sosne G, Dunn SP, Kim C. Thymosin beta4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial. Cornea. 2015 May;34(5):491-6. doi: 10.1097/ICO.0000000000000379.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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Put the record in context.

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TrialsThymosin Beta-4 trial dashboard →DatabaseThymosin Beta-4 database entry →ResearchThymosin Beta-4 research guide →