Dry Eye SyndromePhase 2/3NCT02597803
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
A Phase 2/3 study testing RGN-259 in people with Dry Eye Syndrome, run by ReGenTree, LLC at 1 site 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
- 317 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jul 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 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
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 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
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-1
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 |
|---|---|---|
| High Dose RGN-259 | Experimental | High dose 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 |
| Low Dose RGN-259 | Experimental | Low dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4 Receives: Drug: RGN-259 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total corneal fluorescein staining score at day29
Measured: 29 days after first dosing
Total ocular discomfort score at day29
Measured: 29 days after first dosing
Secondary outcomes (3)
Tear film break-up time at day 8, 15, 29
Measured: 8, 15, 29 days after first dosing
Unanesthetized Schirmer's Test at day 8, 15, 29
Measured: 8, 15, 29 days after first dosing
Ocular Surface Disease Index (OSDI)© at day 8, 15, 29
Measured: 8, 15, 29 days after first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 317 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
- NCT02597803
- Sponsor's protocol ID
- RGN-259
- Status last verified
- Oct 2019
- First submitted
- 26 Oct 2015
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. 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-1
- ClinicalTrials.gov ID
- NCT02597803
- Acronym / sponsor ID
- RGN-259
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry Eye Syndrome, Dry Eye, DES
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- ReGenTree, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
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
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose RGN-259 | Experimental | Drug: RGN-259High dose RGN-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 |
| Low Dose RGN-259 | Experimental | Drug: RGN-259Low dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 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 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;
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 | High Dose RGN-259, Low Dose RGN-259 |
| PlaceboAlso: Vehicle ControlIt is composed of the same excipients as RGN-259 but does not contain Tβ4 | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RGN-259 in people with Dry Eye Syndrome, run by ReGenTree, LLC at 1 site 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 7 inclusion and 9 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 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total corneal fluorescein staining score at day29 (time frame: 29 days after first dosing). 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 17 Oct 2019.