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Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

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ClinicalTrials.gov Identifier: NCT02597803
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
ReGenTree, LLC

Tracking Information
First Submitted Date  ICMJE October 26, 2015
First Posted Date  ICMJE November 5, 2015
Last Update Posted Date October 17, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • Total corneal fluorescein staining score at day29 [ Time Frame: 29 days after first dosing ]
  • Total ocular discomfort score at day29 [ Time Frame: 29 days after first dosing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02597803 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • Tear film break-up time at day 8, 15, 29 [ Time Frame: 8, 15, 29 days after first dosing ]
  • Unanesthetized Schirmer's Test at day 8, 15, 29 [ Time Frame: 8, 15, 29 days after first dosing ]
  • Ocular Surface Disease Index (OSDI)© at day 8, 15, 29 [ Time Frame: 8, 15, 29 days after first dosing ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 23, 2016)
  • Visual acuity ( ETDRS, Early Treatment Diabetic Retinopathy Study scale) at 1, 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
  • Change in biomicroscopy using slit-lamp at 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
  • Corneal Sensitivity (aesthesiometer (Cochet-Bonnet at 1, 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
  • Adverse event query at Visits 1,2,3, 4 and 5 [ Time Frame: 1, 8, 15, 29 days after first dosing ]
  • Change in biomicroscopy using Undilated Fundoscopy at 1, 29 days after first dosing [ Time Frame: 1, 29 days after first dosing ]
  • Intraocular Pressure at Visits 1, 29 days after first dosing [ Time Frame: 1, 29 days after first dosing ]
Original Other Pre-specified Outcome Measures
 (submitted: November 4, 2015)
  • Visual acuity ( ETDRS, Early Treatment Diabetic Retinopathy Study scale) at 1, 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
  • Change in biomicroscopy using slit-lamp at 8, 15, 22, 29, 36, 43 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
  • Corneal Sensitivity (aesthesiometer (Cochet-Bonnet at 1, 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
  • Adverse event query at Visits 1,2,3, 4 and 5 [ Time Frame: 1, 8, 15, 29 days after first dosing ]
  • Change in biomicroscopy useing Undilated Fundoscopy at 1, 29 days after first dosing [ Time Frame: 1, 29 days after first dosing ]
  • Intraocular Pressure at Visits 1, 29 days after first dosing [ Time Frame: 1, 29 days after first dosing ]
 
Descriptive Information
Brief Title  ICMJE Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
Official Title  ICMJE A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye: ARISE-1
Brief Summary The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Detailed Description Dry eye can be caused by many variable factors. Some examples include hormonal changes due to aging, or living in an environment of low humidity for long periods of time. Dry eye is a complex disease that may result in symptoms like discomfort, visual disturbance, and dryness. Patients with dry eye often have damage on the surface of the eye. In previous studies, RGN-259 has been shown to promote healing of the surface of the eye and decrease inflammation. It suggests that RGN-259 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndrome
Intervention  ICMJE
  • Drug: RGN-259
    A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days
    Other Names:
    • 4
    • Thymosin Beta 4
  • Drug: Placebo
    It is composed of the same excipients as RGN-259 but does not contain Tβ4
    Other Name: Vehicle Control
Study Arms  ICMJE
  • Experimental: High Dose RGN-259
    High dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4
    Intervention: Drug: RGN-259
  • Placebo Comparator: Placebo
    It is composed of the same excipients as RGN-259 but does not contain Tβ4
    Intervention: Drug: Placebo
  • Experimental: Low Dose RGN-259
    Low dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4
    Intervention: Drug: RGN-259
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2016)
317
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2015)
306
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be at least 18 years of age;
  • Provide written informed consent;
  • Have a subject reported history of dry eye for at least 6 months
  • Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
  • Have a Schirmer's Test score of ≤10mm and ≥1mm
  • Have a Tear Film Break-Up Time (TFBUT) ≤10 seconds
  • Have a corneal fluorescein staining score of ≥2 in at least one region of the cornea

Exclusion Criteria:

  • Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
  • Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
  • Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
  • Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 6 months;
  • Have an IOP > 25 mmHg at Visit 1;
  • Have any planned ocular and/or lid surgeries over the study period;
  • Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
  • Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study);
  • Have corrected visual acuity greater than or equal to logMAR +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02597803
Other Study ID Numbers  ICMJE RGN-259
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ReGenTree, LLC
Study Sponsor  ICMJE ReGenTree, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gail Torkildsen, MD Ora Clinical Research and Development
PRS Account ReGenTree, LLC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP