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Peptide

Thymosin Beta 4 eye drops for Sjogren's Syndrome

Phase 2
Waitlist Available
Led By Steven P Dunn, M.D.
Research Sponsored by Michigan Cornea Consultants, PC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 14, day 28 and day 56

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.

Eligible Conditions
  • Sjogren's Syndrome
  • Graft-versus-Host Disease
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 14, day 28 and day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 14, day 28 and day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety
Secondary study objectives
Corneal Fluorescein Staining
Ocular Discomfort Index
Tear Film Break up Time

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Thymosin Beta 4 eye dropsExperimental Treatment1 Intervention
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days
Group II: Vehicle ControlPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thymosin beta-4
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Michigan Cornea Consultants, PCLead Sponsor
Kresge Eye InstituteOTHER
3 Previous Clinical Trials
229 Total Patients Enrolled
Steven P Dunn, M.D.Principal InvestigatorMichigan Cornea Consultants, P.C.
~1 spots leftby Nov 2025