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

NCT ID: NCT01393132

Last Updated: 2015-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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See above

Conditions

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Dry Eye Sjogren's Syndrome Graft vs. Host Disease

Keywords

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Dry Eye Sjogren's Syndrome Graft vs. Host Disease Rheumatoid arthritis Systemic lupus erythematosus Scleroderma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Thymosin Beta 4 eye drops

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Vehicle Control

Intervention Type DRUG

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

Interventions

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Thymosin Beta 4 eye drops

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

Intervention Type DRUG

Vehicle Control

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

Intervention Type DRUG

Other Intervention Names

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Tβ4 Vehicle

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kresge Eye Institute

OTHER

Sponsor Role collaborator

Michigan Cornea Consultants, PC

OTHER

Sponsor Role lead

Responsible Party

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Steven P. Dunn, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven P Dunn, M.D.

Role: PRINCIPAL_INVESTIGATOR

Michigan Cornea Consultants, P.C.

Locations

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Michigan Cornea Consultants, P.C.

Southfield, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25826322 (View on PubMed)

Other Identifiers

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1003008179

Identifier Type: -

Identifier Source: org_study_id