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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 : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
ReGenTree, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: RGN-259 Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: High Dose RGN-259
High dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4
 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:
  • Tβ4
  • Thymosin Beta 4
Placebo Comparator: Placebo
It is composed of the same excipients as RGN-259 but does not contain Tβ4
 Drug: Placebo
It is composed of the same excipients as RGN-259 but does not contain Tβ4
Other Name: Vehicle Control
Experimental: Low Dose RGN-259
Low dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4
 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:
  • Tβ4
  • Thymosin Beta 4


Outcome Measures
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Primary Outcome Measures :
  1. Total corneal fluorescein staining score at day29 [ Time Frame: 29 days after first dosing ]
  2. Total ocular discomfort score at day29 [ Time Frame: 29 days after first dosing ]

Secondary Outcome Measures :
  1. Tear film break-up time at day 8, 15, 29 [ Time Frame: 8, 15, 29 days after first dosing ]
  2. Unanesthetized Schirmer's Test at day 8, 15, 29 [ Time Frame: 8, 15, 29 days after first dosing ]
  3. Ocular Surface Disease Index (OSDI)© at day 8, 15, 29 [ Time Frame: 8, 15, 29 days after first dosing ]

Other Outcome Measures:
  1. 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 ]
  2. Change in biomicroscopy using slit-lamp at 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
  3. Corneal Sensitivity (aesthesiometer (Cochet-Bonnet at 1, 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
  4. Adverse event query at Visits 1,2,3, 4 and 5 [ Time Frame: 1, 8, 15, 29 days after first dosing ]
  5. Change in biomicroscopy using Undilated Fundoscopy at 1, 29 days after first dosing [ Time Frame: 1, 29 days after first dosing ]
  6. Intraocular Pressure at Visits 1, 29 days after first dosing [ Time Frame: 1, 29 days after first dosing ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597803


Locations
United States, Massachusetts
Andover, MA
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
ReGenTree, LLC
Investigators
Principal Investigator: Gail Torkildsen, MD Ora Clinical Research and Development
More Information
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Responsible Party: ReGenTree, LLC
ClinicalTrials.gov Identifier: NCT02597803     History of Changes
Other Study ID Numbers: RGN-259
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ReGenTree, LLC:
Dry Eye Syndrome
Dry Eye
DES

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions