Evaluation of FID 114657 in Sjogren's Syndrome Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the overall Sjogren's Syndrome subject's preference for a particular product. Dry eye symptom relief will also be evaluated based on clinical evaluation and a set of subject questionnaires.

Conditions
-----------------
Sjogren's Syndrome

Intervention / Treatment
-----------------
* Other: FID 114657 (ORB Preserved Ocular Emulsion)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be at least 18 years of age, must read and sign the informed consent form (ICF), and must agree to comply with the study requirements. Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye, must report having an ocular examination in the last two years and must be using topical ocular dry eye therapy (artificial tears or Restasis) at least 4 times per day. Patients must have been diagnosed with Sjogren's Syndrome (confirmed or consistent with the American-European Consensus Criteria 2002). Exclusion Criteria: Patients cannot wear contact lenses within one week prior to visit 1 and cannot wear their contact lenses during the study. Patients cannot have a history of hypersensitivity to any component of FID 114657, and cannot have diabetes (Type 1 or 2). Patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have an eyelid abnormality that might affect lid function. Patients cannot have punctal plugs that were placed less than or equal to 30 days prior to Visit 1, and cannot have active infections or inflammations not associated with Sjogren's Syndrome. They cannot have started or changed the dose of chronic systemic medication within 7 days prior to visit 1, and must remain on a stable dosing regimen for the duration of the study. Patients cannot have participated in another investigational clinical or research study within 30 days of visit 1 and are not allowed to participate in any other drug or device clinical trial for the duration of this study. Patients cannot have any findings in the vitreous, retina, macula and choroid that show signs of active inflammation and/or any structural change that in the opinion of the investigator is considered abnormal or unstable for that participant and/or a score of greater than 0 for the optic nerve. Patients can not have had punctal cauterization within 30 days prior to Visit 1, have a history of undergoing prior cataract surgery with complications as a result of the cataract surgery. Participants who have undergone prior cataract surgery without complications must be at least six months post-op with a stable refractive error. Patients cannot have received ocular prescription therapy in the last 30 days (Restasis can be used as long as stable for at least 30 days).

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 114657 (ORB Preserved Ocular Emulsion)<br>ORB Preserved Ocular Emulsion dosed as needed throughout the day (PRN) | Other: FID 114657 (ORB Preserved Ocular Emulsion)<br>* Patients will dose as needed throughout the day (PRN) for 4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference based on subject's relief of dry eye |  | 5 weeks | 

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