Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ReGenTree, LLC
• Collaborator: ORA, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Tetrahydrozoline

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.