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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3

Short name ARISE-3

NCTNCT03937882 (opens ClinicalTrials.gov in a new tab)Other idRGN-259/19-110-0002
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
700 participants (actual)
Sponsor
ReGenTree, LLC · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
24 May 2019
Primary completion
8 Nov 2020
Completion
7 Oct 2021
First posted
6 May 2019
Last update posted
28 Aug 2026
Conditions
Dry Eye Syndromes · Dry Eye

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 3

    ARISE-3

    NCT03937882

    24 May 2019 to 7 Oct 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Interventions

  • RGN-259Drug
  • PlaceboDrug

Arms2

  • Experimental

    RGN-259

    RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4

  • Placebo comparator

    Placebo

    It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Inferior Corneal Staining Change From Pre-CAE®(Controlled Adverse Environment) to Post-CAE® at Day 15 (Visit 4) Using the Ora Calibra® Scale

    Time frame · Day 15

    Registry description

    Inferior corneal staining was assessed using the Ora Calibra® Corneal and Conjunctival Staining Scale, which is a 0 to 4 scale and where higher numbers indicating more severe staining.

  2. Change From Baseline in Ocular Discomfort at Day 15 (Visit 4) Pre-CAE® Using the Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire

    Time frame · Day 15

    Registry description

    The severity of ocular discomfort was measured using the Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire which is a 0 to 5 scale and where higher numbers indicating more severe discomfort.

Secondary outcomes(9)

  1. Fluorescein Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre and Post-CAE®)

    Time frame · Day 8, Day 15

    Registry description

    Corneal and conjunctival staining were assessed using the Ora Calibra® Corneal and Conjunctival Staining Scale, which is a 0 to 20 scale and where higher numbers indicating more severe staining.

  2. Lissamine Green Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®)

    Time frame · Day 8, Day 15

    Registry description

    Lissamine green staining were assessed using the Ora Calibra® Corneal and Conjunctival Staining Scale, which is a 0 to 20 scale and where higher numbers indicating more severe staining.

  3. Tear Film Break-Up Time (TFBUT©) at Visits 3 and 4 (Pre- and Post-CAE®)

    Time frame · Day 8, Day 15

    Registry description

    TFBUT© measures tear film stability and was assessed by measuring, in seconds, the time from eye opening to the formation of micelles in the tear film. Measurements were obtained using a stopwatch. Longer TFBUT values indicate greater tear film stability and less severe dry eye.

  4. Unanesthetized Schirmer's Test at Visit 3, Visit 4 (Pre-CAE®)

    Time frame · Day 8, Day 15

    Registry description

    The Unanesthetized Schirmer's Test measures tear production. A sterile Schirmer test strip was placed in the lower temporal lid margin of each eye, and after 5 minutes, the length of the moistened area on the strip was recorded in millimeters (mm). Higher values indicate greater tear production and a better outcome.

  5. Drop Comfort Assessment After Randomization at Visit 2

    Time frame · Day 1

    Registry description

    Drop comfort for each eye was assessed using subject-reported drop comfort scale, which is a 0 to 10 scale and where higher numbers indicating more uncomfortable.

  6. Ocular Surface Disease Index (OSDI)© at Visits 3 and 4 (Pre-CAE®)

    Time frame · Day 8, Day 15

    Registry description

    The severity of dry eye disease and its impact on vision-related function were measured using the Ocular Surface Disease Index. Scores range from 0 to 100, with higher scores indicating greater disability.

  7. Ocular Discomfort & 4-Symptom Questionnaire at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®), Excluding the Hierarchical Efficacy Measure

    Time frame · Day 8, Day 15

    Registry description

    The severity of 5 symptoms was measured using the Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire which is a 0 to 5 scale and where higher numbers indicating more severe discomfort.

  8. Ocular Discomfort Outside CAE® at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®)

    Time frame · Day 8, Day 15

    Registry description

    Subjects' perceived severity of ocular discomfort was measured using the Ocular Discomfort Scale which is a 0 to 4 scale and where higher numbers indicating more severe discomfort.

  9. Ocular Discomfort During CAE® at Visit 4

    Time frame · Day 15

    Registry description

    Subjects' perceived severity of ocular discomfort during CAE® exposure was measured using the Ocular Discomfort Scale which is a 0 to 4 scale and where higher numbers indicating more severe discomfort.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Day 15

Change From Baseline in Inferior Corneal Staining Change From Pre-CAE®(Controlled Adverse Environment) to Post-CAE® at Day 15 (Visit 4) Using the Ora Calibra® Scale

GroupValue (Score on a scale)Spread
Experimental: RGN-259-0.410.841
Placebo Comparator: Placebo-0.460.804
Primary outcomeMean· Day 15

Change From Baseline in Ocular Discomfort at Day 15 (Visit 4) Pre-CAE® Using the Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire

GroupValue (Score on a scale)Spread
Experimental: RGN-259-0.41.12
Placebo Comparator: Placebo-0.41.14
Secondary and other outcome results(6)
Secondary outcomeMean· Day 8, Day 15

Fluorescein Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre and Post-CAE®)

GroupValue (Score on a scale)Spread
Experimental: RGN-2598.462.960
Placebo Comparator: Placebo8.362.885
Secondary outcomeMean· Day 8, Day 15

Lissamine Green Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®)

GroupValue (Score on a scale)Spread
Experimental: RGN-2595.713.192
Placebo Comparator: Placebo5.713.106
Secondary outcomeMean· Day 8, Day 15

Tear Film Break-Up Time (TFBUT©) at Visits 3 and 4 (Pre- and Post-CAE®)

GroupValue (Seconds)Spread
Experimental: RGN-2593.17821.34370
Placebo Comparator: Placebo3.21861.20830
Secondary outcomeMean· Day 8, Day 15

Unanesthetized Schirmer's Test at Visit 3, Visit 4 (Pre-CAE®)

GroupValue (mm)Spread
Experimental: RGN-2595.34.36
Placebo Comparator: Placebo5.95.05
Secondary outcomeMean· Day 1

Drop Comfort Assessment After Randomization at Visit 2

GroupValue (Score on a scale)Spread
Experimental: RGN-2592.22.31
Placebo Comparator: Placebo2.02.23
Secondary outcomeMean· Day 8, Day 15

Ocular Surface Disease Index (OSDI)© at Visits 3 and 4 (Pre-CAE®)

GroupValue (Score on a scale)Spread
Experimental: RGN-25932.219.74
Placebo Comparator: Placebo33.719.64

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Experimental: RGN-259It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days0 / 3500 / 35047 / 350
Placebo Comparator: PlaceboIt is composed of the same excipients as RGN-259 but does not contain Tβ40 / 3490 / 34931 / 349

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Be at least 18 years of age; * Provide written informed consent; * Have a subject reported history of dry eye prior to Visit 1; * Have a history of use or desire to use eye drops for dry eye symptoms 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 used any eye drops within 2 hours of Visit 1; * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 6 months; * Have used Restasis®, Xiidra® Cequa®, or TrueTear® within 45 days of Visit 1 or Lipiflow® within 6 months of Visit 1; * Have an intraocular pressure (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 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 logarithm of the minimum angle of resolution (logMAR) +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1; * Have an uncontrolled systemic disease; * Be a woman who is pregnant, nursing or planning a pregnancy; * Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential. Non-childbearing potential is defined as a woman who is permanently sterilized (e.g., has had a hysterectomy or bilateral tubal ligation or bilateral oophorectomy), or is post-menopausal (without menses for 12 consecutive months); * Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; intrauterine device (IUD); or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study; * Have a known allergy and/or sensitivity to the study drug or its components; * Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; * Have used an investigational drug or device within 30 days of Visit 1; * Be currently using any medication known to cause ocular drying (e.g., antihistamines, anti-depressants) or increased lacrimation (e.g., cholinergics) that is not used on a stable dosing regimen for at least 30 days prior to Visit 1; * Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids), ophthalmic topical steroids, topical nonsteroidal antiinflammatory drugs (NSAIDs), topical antibiotics, immunotherapy, or cytotoxic therapy within 14 days of Visit 1 or anticipate such therapy throughout the study period. * Be unable or unwilling to follow instructions, including participation in all study assessments and visits.

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