Clinical trial NCT02974907: Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndrome
Keywords: Dry Eye Syndrome
Dry Eye
DES
Lead sponsor: ReGenTree, LLC
Sponsor class: INDUSTRY
First posted: 2016-11-29
Enrollment: 601
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

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 ab uncontrolled systemic disease:

Primary outcomes:
measure: Ocular Discomfort
timeFrame: 29 days after first dosing
measure: Corneal Fluorescein Staining
timeFrame: 29 days after first dosing
Secondary outcomes:
measure: Corneal Fluorescein Staining
timeFrame: 8, 15, 29 days after first dosing
measure: Unanesthetized Schirmer's Test
timeFrame: 29 days after first dosing
measure: Ocular Surface Disease Index (OSDI)©
timeFrame: 8, 15, 29 days after first dosing
measure: Tear Film Break-Up Time
timeFrame: 8, 15, 29 days after first dosing
Other outcomes:
measure: Visual Acuity
timeFrame: 1, 8, 15, 29 days
measure: Change in Biomicroscopy Using the Slit-lamp
timeFrame: 1, 8, 15, 29 days
measure: Adverse Event Query
timeFrame: 1, 8, 15, 29 days
measure: Change in Biomicroscopy Using the Undilated Fundoscopy
timeFrame: 1, 29 days
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: