NGF0221

The purpose of this research study is to find out more about the study drug, cenegermin 20mcg/mL ophthalmic solution, in people with severe Sjogren’s dry eye disease. The study will see if cenegermin can safely and effectively relieve the signs and symptoms of this condition, and whether it causes side effects. You will be in this research study for 25 weeks (6 months). If you are eligible to participate in the study, you will be asked to self-administer the study eye drops (cenegermin or placebo) 3 times per day (one drop in both eyes every 6-8 hours) for 4 weeks. Once you have finished 4 weeks of using the study eye drops, you will continue in the study for an additional 20 weeks, so your study doctor can monitor your eyes and health for any side effects. You will be asked to continue your Cyclosporine A eye drops during your study duration, which you were taking prior to enrollment.

You will also be asked to attend the eye clinic for 8 visits. These visits can take up to two hours. At each visit, the study team will ask you about your medical history, symptoms and medications. Your study doctor will also conduct an eye examination. All of the eye examination procedures are considered routine for people with severe Sjogren’s DED.

Inclusion Criteria

1. confirmed diagnosis of Sjogren syndrome or other autoimmune disease known to induce Sjogren’s Dry Eye Disease (DED) at least 3 months prior to enrollment;
2. patients with severe Sjogren’s dry eye disease characterized by the following clinical features:

1. corneal and/or conjunctival staining with fluorescein using National Eye Institute (NEI) grading system ≥ 3;
2. SANDE questionnaire global score > 25 mm
3. Schirmer test I (without anesthesia) ≥ 2 ≤ 5 mm/5 min

3) Best corrected distance visual acuity (BCDVA) better than 20/200 Snellen value in each eye at the time of study enrollment

Exclusion Criteria

1. Evidence of an active ocular infection, in either eye
2. Presence of any other ocular disorder or condition requiring topical medication (excluding Cyclosporine A) during the entire duration of the study in either eye
3. History of severe systemic allergy or of ocular allergy (including seasonal conjunctivitis or chornic conjunctivitis and/or keratitis other than dry eye)

Study Requirements

Subjects will undergo a 4 week masked treatment phase, while continuing their daily Cyclosporine A eye drops as prescribed prior to study enrollment. Subjects will be assigned to one of two groups: cenergermin 20mcg/mL three times daily, or vehicle/placebo drops 3 times daily. Once randomized, subjects will return for an additional 20 weeks for safety evaluations. Visits will include various eye exams, for both visual acuity and ocular surface health.