Severe Sjogren’s dry eye disease MedDRA version: 21.0 Level: LLT Classification code 10040766 Term: Sjogren's disease System Organ Class: 100000004859
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
Curren
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 Sjogren syndrome or other autoimmune disease known to induce Sjogren’s Dry Eye Disease (DED). 3. Patients with severe Sjogren’s dry eye disease 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 global score >25 mm c. Schirmer test I (without anaesthesia) =2 =5mm/5min 4. The same eye (eligible eye) must fulfill all the above criteria 5. Diagnosis of severe Sjogren’s dry eye disease 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. Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the IRB/IEC for the current study 9. Patients must have the ability and willingness to comply with study procedures 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
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 with a history of serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or 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 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 cyclosporine, or topical ophthalmic treatments of the same class, within 14 days of screening visit (day -8). 12. 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) 13. 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) 14. History of drug addiction or alcohol abuse within the last year 15. Any prior ocular surgery (including refractive, palpebral and cataract surgery) if within 60 days before the screening visit 16. Participation in a clinical trial with a new active substance during the past 3 months prior to screening 17. 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: Not applicable;Primary end point(s): •Schirmer I test (without anesthesia) >10mm/5min at week 4 in the eligible eye. •Change from baseline in Symptoms questionnaire (SANDE) global score at week 12.;Timepoint(s) of evaluation of this end point: Week 4 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline in Schirmer I test (without anesthesia); • Change from baseline in Cornea and conjunctiva vital staining with fluorescein (National Eye Institute [NEI] scales); • Change from baseline in Tear Film Break-Up Time (TFBUT); • Change from baseline in Symptoms questionnaire (SANDE) scores for severity and frequency; • Number of patients experienced a worsening in symptom scores (SANDE) and/or NEI score = 50% assessed at week 4; • Quality of life (IDEEL) questionnaire; 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 Symptoms questionnaire (SANDE) scores for severity and frequency; Change from baseline in Cornea and conjunctiva vital staining with fluorescein (National Eye Institute [NEI] scales) Vs week 2; Change from baseline in Tear Film Break-Up Time (TFBUT) Vs week 2; Number of patients experienced a worsening in symptom scores (SANDE) and/or NEI score = 50% assessed at week 2; Change from baseline Schimer test II (with topical Anesthesia) vs Week 4; Change from baseline in BCDVA; Incidence and frequency of Treatment-emergent adverse events (TEAEs), assessed throughout the study.;Timepoint(s) of evaluation of this end point: week 4, 8, 12 and 16; week 4, 8, 12 and 16; week 4, 8, 12 and 16; week 8, 12 and 16; week 4; week 4, 8, 12 and 16; treatment period; follow-up period; from baseline; week 2; week 2 and 4; from baseline; settimana 2; from baseline; week 2; week 2; from baseline; week 2; from baseline; throughout the study | — |
Countries
Italy, United States
Contacts
Public ContactClinical Trial manager
Dompé farmaceutici S.p.A.
Outcome results
None listed