We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Dry Eye Sjogren's Syndrome Graft vs. Host Disease Drug: Thymosin Beta 4 eye drops Drug: Vehicle Control Phase 2

Detailed Description:
See above

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye
Study Start Date : March 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Arms and Interventions

Arm Intervention/treatment
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
Drug: Thymosin Beta 4 eye drops
Patients will be randomized and will receive the same eye drops the Thymosin Beta 4.
Other Name: Tβ4
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.
Drug: Vehicle Control
Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.
Other Name: Vehicle

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393132

United States, Michigan
Michigan Cornea Consultants, P.C.
Southfield, Michigan, United States, 48034
Sponsors and Collaborators
Michigan Cornea Consultants, PC
Kresge Eye Institute
Principal Investigator: Steven P Dunn, M.D. Michigan Cornea Consultants, P.C.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven P. Dunn, M.D., Principal Investigator, Michigan Cornea Consultants, PC
ClinicalTrials.gov Identifier: NCT01393132     History of Changes
Other Study ID Numbers: 1003008179
First Posted: July 13, 2011    Key Record Dates
Results First Posted: December 23, 2015
Last Update Posted: December 23, 2015
Last Verified: December 2015

Keywords provided by Steven P. Dunn, M.D., Michigan Cornea Consultants, PC:
Dry Eye
Sjogren's Syndrome
Graft vs. Host Disease
Rheumatoid arthritis
Systemic lupus erythematosus

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Sjogren's Syndrome
Graft vs Host Disease
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs