A 4-week,Phase III, Multicenter, Double-masked, Vehicle-controlled Clinical Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) 20 mcg/mL Ophthalmic Solution Versus Vehicle, in Patients With Severe Sjogren's Dry Eye Disease Under Treatment With Cyclosporine A (PROTEGO-2 Study).

NGF0221

The study objective is to assess the efficacy and safety of cenegermin (rhNGF) ophthalmic solution at 20 mcg/mL concentration administered three times daily for 4 weeks in patients with severe Sjogren's dry eye disease (DED) who are under chronic treatment with topical Cyclosporine A (CsA).

2022-01-27

2023-03-02

2023-05-24

Completed

Early phase I

85

Inclusion Criteria: 1. Male or female aged ≥ 18 years 2. Patients with a confirmed diagnosis of Sjogren syndrome or other autoimmune disease known to induce Sjogren's DED. 3. Patients with severe Sjogren's DED characterized by the following clinical features: 1. Corneal and/or conjunctival staining with fluorescein using National Eye Institute (NEI) grading system ≥3 2. Symptom assessment in dry eye (SANDE) questionnaire global score \>25 mm 3. Schirmer test I (without anaesthesia) between 2 and 5mm/5min, inclusive 4. The same eye (eligible eye) must fulfill all the above criteria 5. Diagnosis of severe Sjogren's DED at least 3 months before enrolment (current use or recommended use of artificial tears for the treatment of Sjogren's related dry eye) 6. Best corrected distance visual acuity (BCDVA) score of ≥ 0 .1 decimal units ( 20/200 Snellen value) in each eye at the time of study enrolment 7. If a female with childbearing potential, have a negative pregnancy test 8. Patients who have given written informed consent before any study-related procedures not part of standard medical care are performed. 9. Patients must have the ability and willingness to comply with study procedures. 10. Patients under treatment with topical cyclosporine (CsA), or topical ophthalmic treatments of the same class for at least 30 days before screening visit (day -8). Exclusion Criteria: 1. Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments 2. Evidence of an active ocular infection, in either eye 3. Presence of any other ocular disorder or condition requiring topical medication during the entire duration of study in either eye 4. History of severe systemic allergy or of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis and/or keratitis other than due to dry eye (DE) 5. Intraocular inflammation defined as Tyndall score \>0 6. History of malignancy in the last 5 years 7. Systemic disease not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or with a condition incompatible with the frequent assessment required by the study 8. Patient with a history of serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or clinically significant allergy to foods, amide local anesthetics or other materials including commercial artificial tears (in the opinion of the investigator) 9. Females of childbearing potential (those who are not surgically sterilized or postmenopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions: 1. are currently pregnant or, 2. have a positive result at the urine pregnancy test (Baseline/Day 1) or, 3. intend to become pregnant during the study treatment period or, 4. are breast-feeding or, 5. are not willing to use highly effective birth control measures, during the entire course of and 30 days after the study treatment period 10. Any concurrent medical condition, that in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being 11. Use of topical corticosteroids, lifitegrast, autologous serum tears in either eye during the study (previous use not an exclusion criteria but must be discontinued at the screening visit) 12. Contact lenses, true tear device, moisture googles, sutureless amniotic membrane or punctum plug use during the study (previous use not an exclusion criteria but must be discontinued at the screening visit) 13. History of drug addiction or alcohol abuse within the last year 14. Any prior ocular surgery (including refractive, palpebral and cataract surgery) if within 90 days before the screening visit 15. Participation in a clinical trial with a new active substance during the past 3 months prior of screening 16. Participation in another clinical trial study at the same time as the present study.

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2023-12-28