Phase 2
N=72
Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye
Dry Eye Syndrome · Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT01387347 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Corneal Staining (Inferior Region) in the Worst Eye in the Controlled Adverse Environment (CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye — 2.08; 1.9 units on a scale — p=0.2596
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Thymosin beta 4 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ReGenTree, LLC
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Staining (Inferior Region) in the Worst Eye in the Controlled Adverse Environment (CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye |
2.08; 1.9 | 0.2596 |
| PRIMARY Ocular Discomfort in the Worst Eye in the Controlled Adverse Environment(CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye. |
1.3; 1.6 | 0.3734 |
| SECONDARY Number of Adverse Events as a Measure of Safety and Tolerability |
2; 0 | — |
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
- Have given a written, informed consent.
- 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.
- Have a best corrected visual acuity.
- Have a patient-reported history of dry eye in both eyes.
- Use and/or desire to use an artificial tear substitute for dry eye symptoms within the past 6 months.
- A negative urine pregnancy test if female of childbearing potential.
- Have a corneal fluorescein staining score of ≥ 2 in any corneal surface segment in at least one eye at Visit 1.
-
Exclusion Criteria
- Have contraindications to the use of the study drug.
- Have known allergy or sensitivity to the study drug or components thereof.
- Have anterior blepharitis.
- Be diagnosed with an on-going ocular infection or active ocular inflammation.
- Use contact lenses within 1 week before Visit 1 or during the course of the study.
- Have previously had Laser-Assisted in Situ Keratomileusis (LASIK) surgery within 12 months prior to Visit 1.
- 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.
- Have used topical ocular cyclosporine within 30 days prior to Visit 1.
- Have had a past or present evidence of malignancy.
Data sourced from ClinicalTrials.gov (NCT01387347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.