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 : October 17, 2019
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Condition or disease | Intervention/treatment | Phase |
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Dry Eye Syndrome | Drug: RGN-259 Drug: Placebo | Phase 2 Phase 3 |
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 |
Arm | Intervention/treatment |
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Experimental: High Dose RGN-259
High dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4
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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:
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Placebo Comparator: Placebo
It is composed of the same excipients as RGN-259 but does not contain Tβ4
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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
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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:
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- 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 ]
- 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 ]
- 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 ]
- Change in biomicroscopy using slit-lamp at 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
- Corneal Sensitivity (aesthesiometer (Cochet-Bonnet at 1, 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
- Adverse event query at Visits 1,2,3, 4 and 5 [ Time Frame: 1, 8, 15, 29 days after first dosing ]
- Change in biomicroscopy using Undilated Fundoscopy at 1, 29 days after first dosing [ Time Frame: 1, 29 days after first dosing ]
- Intraocular Pressure at Visits 1, 29 days after first dosing [ Time Frame: 1, 29 days after first dosing ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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;

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
United States, Massachusetts | |
Andover, MA | |
Andover, Massachusetts, United States, 01810 |
Principal Investigator: | Gail Torkildsen, MD | Ora Clinical Research and Development |
Responsible Party: | ReGenTree, LLC |
ClinicalTrials.gov Identifier: | NCT02597803 |
Other Study ID Numbers: |
RGN-259 |
First Posted: | November 5, 2015 Key Record Dates |
Last Update Posted: | October 17, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Dry Eye Syndrome Dry Eye DES |
Keratoconjunctivitis Sicca Dry Eye Syndromes Syndrome Disease Pathologic Processes Keratoconjunctivitis |
Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases |