Severe Sjogren’s dry eye disease MedDRA version: 21.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Oxervate
Product Name: OXERVATE
Product Code: [Recombinant Human Nerve Growth Factor (rhNGF)]
Pharmaceutical Form: Eye drops
INN or Proposed INN: Cenegermin
CAS Number: 1772578-74-1
Curre
Sponsors
DOMPé FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged = >18 years 2. Patients with a confirmed diagnosis of Sjögren's syndrome or other autoimmune disease known to induce Sjögren’s DED. 3. Patients with severe Sjögren’s DED characterized by the following clinical features: a. Corneal and/or conjunctival staining with fluorescein using National Eye Institute (NEI) grading system = >3 b. SANDE questionnaire >25 mm c. Schirmer test I (without anaesthesia) ) 2 e 5mm/5min inclusive 4. The same eye (eligible eye) must fulfill all the above criteria 5. Patients diagnosed with severe Sjögren’s DED at least 3 months before enrolment (current use or recommended use of artificial tears for the treatment of Sjogren’s related DE) 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
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 dry eye 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 had a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or had a clinically significant allergy to drugs, 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 post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions: a. are currently pregnant or, b. have a positive result at the urine pregnancy test (Baseline/Day 1) or, c. intend to become pregnant during the study treatment period or, d. are breast-feeding or, e. are not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral, implanted, transdermal, or injected - and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or IUD - during the entire course of and 30 days after the study treatment periods 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 in the last 2 years 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 16. Participation in another clinical trial study at the same time as the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy and safety of cenegermin ophthalmic solution at 20 mcg/mL concentration administered three times daily for 4 weeks in patients with severe Sjogren’s dry eye disease.;Secondary Objective: N/A;Primary end point(s): • Schirmer I test (without anesthesia) >10mm/5min at week 4. ;Timepoint(s) of evaluation of this end point: Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline in SANDE global score [Time frame: week 8, 12 and 16]; • Change from baseline in Schirmer I test (without anesthesia) [Time frame: week 4, 8, 12 and 16]; • Change from baseline in Cornea and conjunctiva vital staining with fluorescein (National Eye Institute [NEI] scales) [Time frame: week 4, 8, 12 and 16]; • Change from baseline in Tear Film Break-Up Time (TFBUT) [Time frame: week 4, 8, 12 and 16]; • Change from baseline in SANDE scores for severity and frequency [Time frame: week 8, 12 and 16]; • Number of patients experiencing a worsening in SANDE and/or NEI score = 50% assessed at week 4; • Quality of life (IDEEL) questionnaire [Time frame: week 4, 8, 12 and 16]. Exploratory Endpoints Proportion and frequency of preservative free artificial tears use (n° drops/day) during the treatment period; • Frequency of preservative free artificial tears use (n° drops/day) during the follow up period; • Change from baseline in Schirmer I test (without anesthesia) Vs week 2; • Change from baseline in SANDE global score [Time frame: week 2 and 4]; • Change from baseline in SANDE scores for severity and frequency [Time frame: week 2 and 4]; • Change from baseline in Cornea and conjunctiva vital staining with fluorescein (NEI scales) Vs week 2; • Change from baseline in TFBUT Vs week 2; • Number of patients experiencing a worsening in SANDE and/or NEI score = > 50% assessed at week 2; • Change from baseline in Schirmer test II (with topical Anesthesia) vs Week 4. • Change from baseline in BCDVA Safety Endpoint Incidence and frequency of Adverse Events (AEs) and Treatment-emergent adverse events (TEAEs), assessed throughout the study.;Timepoint(s) of evaluation of this end point: Week 4, 8, 12, 16 | — |
Countries
Italy, United States
Contacts
Public ContactClinical Trial Manager
Dompé farmaceutici S.p.A.,
Outcome results
None listed