Clinical trial NCT02597803: Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye Syndrome
Keywords: Dry Eye Syndrome
Dry Eye
DES
Lead sponsor: ReGenTree, LLC
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Total corneal fluorescein staining score at day29
timeFrame: 29 days after first dosing
measure: Total ocular discomfort score at day29
timeFrame: 29 days after first dosing
Secondary outcomes:
measure: Tear film break-up time at day 8, 15, 29
timeFrame: 8, 15, 29 days after first dosing
measure: Unanesthetized Schirmer's Test at day 8, 15, 29
timeFrame: 8, 15, 29 days after first dosing
measure: Ocular Surface Disease Index (OSDI)© at day 8, 15, 29
timeFrame: 8, 15, 29 days after first dosing
Other outcomes:
measure: Visual acuity ( ETDRS, Early Treatment Diabetic Retinopathy Study scale) at 1, 8, 15, 29 days after first dosing
timeFrame: 1, 8, 15, 29 days after first dosing
measure: Change in biomicroscopy using slit-lamp at 8, 15, 29 days after first dosing
timeFrame: 1, 8, 15, 29 days after first dosing
measure: Corneal Sensitivity (aesthesiometer (Cochet-Bonnet at 1, 8, 15, 29 days after first dosing
timeFrame: 1, 8, 15, 29 days after first dosing
measure: Adverse event query at Visits 1,2,3, 4 and 5
timeFrame: 1, 8, 15, 29 days after first dosing
measure: Change in biomicroscopy using Undilated Fundoscopy at 1, 29 days after first dosing
timeFrame: 1, 29 days after first dosing
measure: Intraocular Pressure at Visits 1, 29 days after first dosing
timeFrame: 1, 29 days after first dosing
Locations:
city: Andover
country: United States
facility: Andover, MA
state: Massachusetts
Study officials:
affiliation: Ora Clinical Research and Development
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References: