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Dry Eye SyndromesPhase 3ARISE-3NCT03937882

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

A Phase 3 study testing RGN-259 in people with Dry Eye Syndromes and Dry Eye, run by ReGenTree, LLC at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Syndromes, Dry Eye
What is being tested?
RGN-259
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
700 participants
Where
20 sitesUnited States
Study dates
24 May 2019to 7 Oct 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 21Show fewer
  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Andover Eye Associates

    Andover, Massachusetts, 01810

  • Texan Eye/Keystone Research

    Austin, Texas, 78731

  • Dovilan Wyatt MD, LLC

    Chicago, Illinois, 60619

  • Vision Institute

    Colorado Springs, Colorado, 80907

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania, 16066

  • Bergstrom Eye Research, LLC

    Fargo, North Dakota, 58103

  • Center For Sight

    Henderson, Nevada, 89052

  • Whitson Vision

    Indianapolis, Indiana, 46240

  • Midwest Cornea Associates, LLC

    Indianapolis, Indiana, 46290

  • Mountain View Eye Center

    Layton, Utah, 84041

  • The Eye Care Institute

    Louisville, Kentucky, 40206

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Total Eye Care, P.A.

    Memphis, Tennessee, 38119

  • Eye Research Foundation

    Newport Beach, California, 92663

  • Country Hills Eye Center

    Ogden, Utah, 84403

  • Cornea and Cataract Consultants of Arizona

    Phoenix, Arizona, 85032

  • Oculus Research, Inc. at the Eye Care Center

    Raleigh, North Carolina, 27603

  • Andover Eye Associates

    Raynham, Massachusetts, 02767

  • Visual Eyes Optometric

    Shelby, North Carolina, 28150

  • Andover Eye Associates

    Warwick, Rhode Island, 02886

Other trials in United States

About this study

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-3)

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.

Being tested
RGN-259, Placebo
Keywords
Dry Eye, Dry Eye Syndrome, DES
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RGN-259Drug

    Also called Tβ4, Thymosin Beta 4

    A preservative-free, sterile eye drop solution containing Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days

  • PlaceboDrug

    Also called Vehicle Control

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

Study groups in NCT03937882
Study groupRoleWhat they receive
RGN-259ExperimentalRGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4
Receives: Drug: RGN-259
PlaceboPlacebo comparatorIt is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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.

    Measured: Day 15

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

    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.

    Measured: Day 15

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®)

    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.

    Measured: Day 8, Day 15

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

    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.

    Measured: Day 8, Day 15

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

    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.

    Measured: Day 8, Day 15

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

    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.

    Measured: Day 8, Day 15

  5. Drop Comfort Assessment After Randomization at Visit 2

    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.

    Measured: Day 1

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

    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.

    Measured: Day 8, Day 15

  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

    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.

    Measured: Day 8, Day 15

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

    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.

    Measured: Day 8, Day 15

  9. Ocular Discomfort During CAE® at Visit 4

    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.

    Measured: Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start24 May 2019
  3. Primary completion8 Nov 2020
  4. Study completion7 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized in a 1:1 ratio RGN-259 to placebo ophthalmic solution.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03937882
Sponsor's protocol ID
RGN-259/19-110-0002
Acronym
ARISE-3
Status last verified
Nov 2021
First submitted
1 May 2019
Last updated
28 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RGN-259 in people with Dry Eye Syndromes and Dry Eye, run by ReGenTree, LLC at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03937882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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