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

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ClinicalTrials.gov Identifier: NCT01393132
Recruitment Status : Completed
First Posted : July 13, 2011
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Collaborator:
Kresge Eye Institute
Information provided by (Responsible Party):
Steven P. Dunn, M.D., Michigan Cornea Consultants, PC

Tracking Information
First Submitted Date  ICMJE July 7, 2011
First Posted Date  ICMJE July 13, 2011
Results First Submitted Date  ICMJE December 8, 2015
Results First Posted Date  ICMJE December 23, 2015
Last Update Posted Date December 23, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
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).
Change History Complete list of historical versions of study NCT01393132 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
Snellen visual acuity - Change from baseline [ Time Frame: 30 days ]
Snellen visual acuity will be measured using standardized eye charts and lighting conditions.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Official Title  ICMJE Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye
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.

Detailed Description See above
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Eye
  • Sjogren's Syndrome
  • Graft vs. Host Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2015)
9
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2011)
20
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01393132
Other Study ID Numbers  ICMJE 1003008179
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven P. Dunn, M.D., Michigan Cornea Consultants, PC
Study Sponsor  ICMJE Michigan Cornea Consultants, PC
Collaborators  ICMJE Kresge Eye Institute
Investigators  ICMJE
Principal Investigator: Steven P Dunn, M.D. Michigan Cornea Consultants, P.C.
PRS Account Michigan Cornea Consultants, PC
Verification Date December 2015

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