Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

Study Overview
=================
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.

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

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: RGN-259
* Drug: Placebo


Participation Criteria
=================
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose RGN-259<br>High dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4 | Drug: RGN-259<br>* A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days<br>* Other names: Thymosin Beta 4;|
| Placebo Comparator: Placebo<br>It is composed of the same excipients as RGN-259 but does not contain Tβ4 | Drug: Placebo<br>* It is composed of the same excipients as RGN-259 but does not contain Tβ4<br>* Other names: Vehicle Control;|
| Experimental: Low Dose RGN-259<br>Low dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4 | Drug: RGN-259<br>* A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days<br>* Other names: Thymosin Beta 4;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total corneal fluorescein staining score at day29 |  | 29 days after first dosing | 
| Total ocular discomfort score at day29 |  | 29 days after first dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film break-up time at day 8, 15, 29 |  | 8, 15, 29 days after first dosing | 
| Unanesthetized Schirmer's Test at day 8, 15, 29 |  | 8, 15, 29 days after first dosing | 
| Ocular Surface Disease Index (OSDI)© at day 8, 15, 29 |  | 8, 15, 29 days after first dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye Syndrome, Dry Eye, DES