Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye
Condition: Dry Eye Syndrome; Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Thymosin beta 4; Placebo
Intervention description: A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.; A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Thymosin beta 4; Dry eye syndrome; Dry eye

Summary:

      Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide
      that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal,
      ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated that
      Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259
      (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product
      that meets a major unmet medical need in patients with dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have given a written, informed consent.

          2. Be able and willing to follow instructions, including participation in study
             assessments, and be present for the required study visits for the duration of the
             study.

          3. Have a best corrected visual acuity.

          4. Have a patient-reported history of dry eye in both eyes.

          5. Use and/or desire to use an artificial tear substitute for dry eye symptoms within the
             past 6 months.

          6. A negative urine pregnancy test if female of childbearing potential.

          7. Have a corneal fluorescein staining score of ≥ 2 in any corneal surface segment in at
             least one eye at Visit 1.

             -

        Exclusion Criteria:

          1. Have contraindications to the use of the study drug.

          2. Have known allergy or sensitivity to the study drug or components thereof.

          3. Have anterior blepharitis.

          4. Be diagnosed with an on-going ocular infection or active ocular inflammation.

          5. Use contact lenses within 1 week before Visit 1 or during the course of the study.

          6. Have previously had Laser-Assisted in Situ Keratomileusis (LASIK) surgery within 12
             months prior to Visit 1.

          7. Be currently taking any topical ophthalmic prescription or over-the-counter (OTC)
             solutions, artificial tears, gels, or scrubs and cannot discontinue these medications
             for the duration of the trial.

          8. Have used topical ocular cyclosporine within 30 days prior to Visit 1.

          9. Have had a past or present evidence of malignancy.