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

This study has been completed.
Sponsor:
Collaborator:
Kresge Eye Institute
Information provided by (Responsible Party):
Steven P. Dunn, M.D., Michigan Cornea Consultants, PC
ClinicalTrials.gov Identifier:
NCT01393132
First received: July 7, 2011
Last updated: December 21, 2015
Last verified: December 2015
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Michigan Cornea Consultants, PC:

Primary Outcome Measures:
  • Safety [ Time Frame: Day 1, Day 14, Day 28 and Day 56 ] [ Designated as safety issue: No ]
    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:
  • Corneal Fluorescein Staining [ Time Frame: Days 56 (+28 day follow up) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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).



Enrollment: 9
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
See above
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393132

Locations
United States, Michigan
Michigan Cornea Consultants, P.C.
Southfield, Michigan, United States, 48034
Sponsors and Collaborators
Michigan Cornea Consultants, PC
Kresge Eye Institute
Investigators
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 
Study First Received: July 7, 2011
Results First Received: December 8, 2015
Last Updated: December 21, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on December 08, 2016