Dry Eye SyndromePhase 3NCT02974907
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
A Phase 3 study testing RGN-259 in people with Dry Eye Syndrome, run by ReGenTree, LLC at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- RGN-259
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 601 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2016to Mar 2018
- 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 an uncontrolled systemic disease.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Vision Institute
Colorado Springs, Colorado, 80907
Eye Consultants of Texas
Grapevine, Texas, 76051
Midwest Cornea Associates, LLC
Indianapolis, Indiana, 46290
Eye Care Institute
Louisville, Kentucky, 40206
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Nashville Vision Associates
Nashville, Tennessee, 37205
Eye Research Foundation
Newport Beach, California, 92663
Cornea & Cataract Consultants of Arizona
Phoenix, Arizona, 85032
The Eye Care Group
Waterbury, Connecticut, 06708
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-2
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.
Read the 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.
- Conditions
- Dry Eye Syndrome
- Being tested
- RGN-259, Placebo
- Keywords
- Dry Eye Syndrome, Dry Eye, 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 Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days
PlaceboDrug
Also called Vehicle Control
It is composed of the same excipients as RGN-259 but does not contain Tβ4
| Study group | Role | What they receive |
|---|---|---|
| RGN-259 | Experimental | RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4 Receives: Drug: RGN-259 |
| Placebo | Placebo comparator | It is composed of the same excipients as RGN-259 but does not contain Tβ4 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ocular Discomfort
Change from baseline in ocular discomfort change from Pre-Controlled Adverse Environment (CAE) to post-CAE at Day 29 (Visit 5) using the Ora Calibra™ Ocular Discomfort Scale
Measured: Day 29
Change in Fluorescein Staining
Change from baseline in staining at Day 29 pre-CAE in using the Ora Calibra™ scale
Measured: Day 29
Secondary outcomes (10)
Fluorescein Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (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, Day 29
Fluorescein Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (Change From Pre-CAE to Post-CAE, Pre- and Post-CAE) in a Subgroup
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, Day 29
Lissamine Green Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (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, Day 29
Tear Film Break-Up Time
Tear film break-up time at Visits 3, 4, and 5 (Pre- and Post-CAE)
Measured: Day 8, Day 15, Day 29
Ocular Protection Index (OPI 2.0) at Visit 5 (Pre-CAE)
Ocular surface drying and tear film stability were measured using the Ora Calibra® OPI 2.0 System. The Ocular Protection Index (OPI) is expressed as the percentage area of tear film breakup and ranges from 0 to 100%, with lower values indicating better ocular surface health.
Measured: Day 29
Unanesthetized Schirmer's Test at Visit 5 (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 29
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
Ocular Surface Disease Index (OSDI)© at Visits 3, 4, and 5 (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, Day 29
Ocular Discomfort and Dry Eye Symptoms at Visits 3, 4, and 5 (Change From Pre-CAE to Post-CAE, Pre- and Post-CAE)
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, Day 29
Ocular Discomfort During CAE at Visits 4 and 5
Subjects' perceived severity of ocular discomfort during CAE exposure was measured using the Ora Calibra® Ocular Discomfort Scale which is a 0 to 4 scale and where higher numbers indicating more severe discomfort.
Measured: Day 15, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReGenTree, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, Ora Clinical Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974907
- Sponsor's protocol ID
- RGN-259/16-110-0008
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2016
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-2
- ClinicalTrials.gov ID
- NCT02974907
- Acronym / sponsor ID
- RGN-259/16-110-0008
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry Eye Syndrome, Dry Eye, DES
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- ReGenTree, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Posted 5 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RGN-259 | Experimental | Drug: RGN-259RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4 |
| Placebo | Placebo comparator | Drug: PlaceboIt is composed of the same excipients as RGN-259 but does not contain Tβ4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (3 listed)
- 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 an uncontrolled systemic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGN-259Also: Tβ4, Thymosin Beta 4A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days | Drug | RGN-259 |
| PlaceboAlso: Vehicle ControlIt is composed of the same excipients as RGN-259 but does not contain Tβ4 | Drug | Placebo |
Primary outcome
Change in Ocular Discomfort
Time frame: Day 29
Change from baseline in ocular discomfort change from Pre-Controlled Adverse Environment (CAE) to post-CAE at Day 29 (Visit 5) using the Ora Calibra™ Ocular Discomfort Scale
Change in Fluorescein Staining
Time frame: Day 29
Change from baseline in staining at Day 29 pre-CAE in using the Ora Calibra™ scale
10 secondary outcomes
Fluorescein Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (Change From Pre-CAE to Post-CAE, Pre- and Post-CAE)
Time frame: Day 8, Day 15, Day 29
Fluorescein Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (Change From Pre-CAE to Post-CAE, Pre- and Post-CAE) in a Subgroup
Time frame: Day 8, Day 15, Day 29
Lissamine Green Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (Pre- and Post-CAE)
Time frame: Day 8, Day 15, Day 29
Tear Film Break-Up Time
Time frame: Day 8, Day 15, Day 29
Ocular Protection Index (OPI 2.0) at Visit 5 (Pre-CAE)
Time frame: Day 29
Unanesthetized Schirmer's Test at Visit 5 (Pre-CAE)
Time frame: Day 29
Drop Comfort Assessment After Randomization at Visit 2
Time frame: Day 1
Ocular Surface Disease Index (OSDI)© at Visits 3, 4, and 5 (Pre-CAE)
Time frame: Day 8, Day 15, Day 29
Ocular Discomfort and Dry Eye Symptoms at Visits 3, 4, and 5 (Change From Pre-CAE to Post-CAE, Pre- and Post-CAE)
Time frame: Day 8, Day 15, Day 29
Ocular Discomfort During CAE at Visits 4 and 5
Time frame: Day 15, Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Torkildsen, MD principal investigator
Ora Clinical Research and Development
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RGN-259 in people with Dry Eye Syndrome, run by ReGenTree, LLC at 10 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 3 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 5 Jan 2022). 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 in Ocular Discomfort (time frame: Day 29). 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?
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 21 Oct 2026.