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

Primary Purpose

Dry Eye Syndrome, Dry Eye

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Thymosin beta 4
Placebo
Sponsored by
ReGenTree, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Thymosin beta 4, Dry eye syndrome, Dry eye

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Thymosin Beta 4

    Placebo

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Number of Adverse Events as a Measure of Safety and Tolerability
    The Adverse events, which will be followed, are: impairment of visual acuity, an increase in intraocular pressure (IOP), and an increase in corneal sensitivity in both eyes.

    Full Information

    First Posted
    June 29, 2011
    Last Updated
    June 10, 2015
    Sponsor
    ReGenTree, LLC
    Collaborators
    ORA, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01387347
    Brief Title
    Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye
    Official Title
    A Double-Masked, Randomized, Single-Center Study Evaluating the Safety and Efficacy of 0.1% Tβ4 Ophthalmic Solution Compared to Vehicle on the Signs and Symptoms of Dry Eye in the Controlled Adverse Environment (CAE) Model
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    October 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ReGenTree, LLC
    Collaborators
    ORA, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Tβ4 promotes wound repair and regeneration in various tissues. In the eye, it promotes corneal epithelial cell migration, decreases inflammation and has anti-apoptotic activities. It up-regulates the gene expression of laminin-5, a major subepithelial adhesion protein, located in the basement membrane region of the cornea, conjunctiva, and important in wound healing. In compassionate-use cases, Tβ4 has demonstrated efficacy in repairing non-healing neurotrophic corneal ulcers and other corneal epithelial wounds. In twenty-four nonclinical toxicology and safety pharmacology studies, the safety of Tβ4 has been demonstrated for its current and planned uses in man. The results of the two recent dry eye murine mouse model studies show that Tβ4 reduced corneal staining more than positive controls and demonstrated statistically significant reduction in staining compared to vehicle control. The results of these studies, in addition to data from compassionate use studies in patients with non-healing corneal surface defects, suggests that Tβ4 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Syndrome, Dry Eye
    Keywords
    Thymosin beta 4, Dry eye syndrome, Dry eye

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Thymosin Beta 4
    Arm Type
    Active Comparator
    Arm Description
    RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Thymosin beta 4
    Other Intervention Name(s)
    Tβ4, RGN-259 (eye drop formulation of Tβ4)
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Vehicle Control
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    Day 29 (end of treatment)
    Title
    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.
    Description
    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.
    Time Frame
    Day 29 (end of treatment)
    Secondary Outcome Measure Information:
    Title
    Number of Adverse Events as a Measure of Safety and Tolerability
    Description
    The Adverse events, which will be followed, are: impairment of visual acuity, an increase in intraocular pressure (IOP), and an increase in corneal sensitivity in both eyes.
    Time Frame
    Throughout the study till Day 29

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gail Torkildsen, MD
    Organizational Affiliation
    Ora Clinical Research and Development
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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