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Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe 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: NCT01393132
Recruitment Status : Completed
First Posted : July 13, 2011
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Information provided by (Responsible Party):

July 7, 2011
July 13, 2011
December 8, 2015
December 23, 2015
December 23, 2015
March 2011
December 2012   (Final data collection date for primary outcome measure)
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).
Corneal and Conjunctival Staining - Change from baseline [ Time Frame: 30 days ]
The corneal and conjunctival surface will be monitored during treatment and for a 30 day period afterwards for improvement of surface staining (using a standardized grading system) and corresponding visual acuity (Snellen) and symptomatic improvement using the validated Ocular Surface Disease Index (OSDI).
Complete list of historical versions of study NCT01393132 on ClinicalTrials.gov Archive Site
  • 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).

Snellen visual acuity - Change from baseline [ Time Frame: 30 days ]
Snellen visual acuity will be measured using standardized eye charts and lighting conditions.
Not Provided
Not Provided
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye

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.

See above
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Dry Eye
  • Sjogren's Syndrome
  • Graft vs. Host Disease
  • Drug: Thymosin Beta 4 eye drops
    Patients will be randomized and will receive the same eye drops the Thymosin Beta 4.
    Other Name: Tβ4
  • Drug: Vehicle Control
    Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.
    Other Name: Vehicle
  • 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
    Intervention: Drug: Thymosin Beta 4 eye drops
  • 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.
    Intervention: Drug: Vehicle Control
Sosne G, Dunn SP, Kim C. Thymosin β4 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Steven P. Dunn, M.D., Michigan Cornea Consultants, PC
Michigan Cornea Consultants, PC
Kresge Eye Institute
Principal Investigator: Steven P Dunn, M.D. Michigan Cornea Consultants, P.C.
Michigan Cornea Consultants, PC
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP