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

NCT01387347 | Completed Phase 2 Results

• 1 other identifier: RGN-DE-202
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dry Eye Syndrome; Dry Eye

Keywords

Thymosin beta 4; Dry eye syndrome; Dry eye

Outcome Measures

Primary Outcomes (2)

• 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

  This is a test that uses orange dye (fluorescein) and a blue light to detect ocular surface defects associated with dry eye. If the test result is normal, the dye remains in the tear film on the surface of the eye and does not adhere to the eye itself. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29. The scale used to determine the difference in corneal fluorescein staining between RGN-259 and placebo is the ORA scale: 0= no staining (no detectable ocular defect)to 4= confluent staining( severe ocular defect). Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes were equal at Visit 2, then the right eye was chosen as the worst eye.

  Day 29 (end of treatment)

• 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.

  Dry eye causes ocular discomfort, which is measured using a validated 4-point ORA Scale from the start of the dosing till the end of treatment (Day 29). 0 = no discomfort to 4 = constant discomfort. If the measurement is lower, then improvement of ocular discomfort can be inferred. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29. Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes had were equal at Visit 2, then the right eye was chosen as the worst eye.

  Day 29 (end of treatment)

Secondary Outcomes (1)

• Number of Adverse Events as a Measure of Safety and Tolerability

  Throughout the study till Day 29

Study Arms (2)

Thymosin Beta 4

ACTIVE COMPARATOR

RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4

Drug: Thymosin beta 4

Placebo

PLACEBO COMPARATOR

The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.

Drug: Placebo

Interventions

Thymosin beta 4 DRUG

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.

Also known as: Tβ4, RGN-259 (eye drop formulation of Tβ4)

Thymosin Beta 4

Placebo DRUG

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.

Also known as: Vehicle Control

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ReGenTree, LLC: lead
• ORA, Inc.: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

thymosin beta(4)

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

There were no limitations to trial RGN-DE-202 entitled:"Safety and Efficacy of Thymosin beta 4 Ophthalmic Solution in Patients with Dry Eye". All subjects were enrolled.

Results Point of Contact

• Title: Won S. Yang, President & CEO
• Organization: ReGenTree, LLC

wonsyang@regentreellc.com

609-734-4328

Study Officials

• Gail Torkildsen, MD

  Ora Clinical Research and Development

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 4, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 10, 2015
• Results First Posted: December 24, 2012

Record last verified: 2012-12