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NCT Number: NCT01393132

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

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Key information

Conditions

Dry Eye Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Graft vs Host Disease Graft vs. Host Disease Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Lupus Erythematosus, Systemic Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Scleroderma, Diffuse Scleroderma, Systemic Sjogren's Syndrome Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Michigan Cornea Consultants, P.C.

Southfield, Michigan, 48034, United States

About this study

See above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thymosin Beta 4 eye drops

Drug

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

Other names: Tβ4

vehicle control

Drug

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

Other names: Vehicle

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Michigan Cornea Consultants, PC

Other

Collaborators

  • Kresge Eye Institute

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 13, 2011
Registry last updated
Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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