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Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (NGF0121) (NGF0121)

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ClinicalTrials.gov Identifier: NCT05133180
Recruitment Status : Recruiting
First Posted : November 24, 2021
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Oxervate Other: Vehicle Phase 3

Detailed Description:

This is a 4 week phase III, multicenter, double-masked, vehicle-controlled study to evaluate safety and efficacy of cenegermin ophthalmic solution at 20 mcg/mL solution versus vehicle, in patients with severe Sjogren's dry eye disease. During the screening all procedures for inclusion will be performed. From the day of screening the patients will stop any kind of further treatment, except commercially available preservative free artificial tears provided by Sponsor.

At the end of the wash out period, patients meeting the entry criteria for this study will be randomized 1:1 and treated for 4 weeks with either cenegermin ophthalmic solution 20 mcg/mL TID or vehicle TID. During the 4 weeks of masked treatment only the administration of IMP is allowed.

During the follow up period, the patient can administer additional artificial tear eye drops, provided by Sponsor, only if strictly needed, and must document in the patient's diary the number of additional drops administered for each eye.

Patients will then be followed up for efficacy and safety endpoints until week 16 and for safety endpoints until week 24.

The total duration of the study is 25 weeks including 1 week of screening.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double-masked study
Primary Purpose: Treatment
Official Title: A 4 Week, Phase III, Multicenter, Double-masked, Vehicle-controlled Study to Evaluate Safety and Efficacy of Oxervate® (Cenegermin) 20 mcg/mL Ophthalmic Solution Versus Vehicle, in Patients With Severe Sjogren's Dry Eye Disease
Actual Study Start Date : January 14, 2022
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Oxervate
one drop of cenegermin 20 mcg/mL will be instilled in both eyes three times daily.
Drug: Oxervate
Oxervate®, an ophthalmic solution containing cenegermin 20 mcg/mL, which is a recombinant human Nerve Growth Factor (rhNGF); one drop of the test product will be instilled in both eyes three times daily (TID).
Other Name: Cenegermin

Placebo Comparator: Vehicle
vehicle eye one drop will be instilled in both eyes three times daily.
Other: Vehicle
Vehicle will be instilled with the same scheme of the test product
Other Name: Reference product




Primary Outcome Measures :
  1. Schirmer I test (without anesthesia) >10mm/5min [ Time Frame: at week 4 ]
    in the eligible eye

  2. Change from baseline in Symptoms questionnaire (SANDE) global score [ Time Frame: at week 12 ]

Secondary Outcome Measures :
  1. Change from baseline in Schirmer I test (without anesthesia) [ Time Frame: At weeks 4, 8, 12 and 16 ]
  2. Change from baseline in Cornea and conjunctiva vital staining with fluorescein(National Eye Institute [NEI] scales) [ Time Frame: At weeks 4, 8, 12 and 16 ]
  3. Change from baseline in Tear Film Break-Up Time (TFBUT) [ Time Frame: At weeks 4, 8, 12 and 16 ]
  4. Change from baseline in Symptoms questionnaire (SANDE) scores for severity and frequency [ Time Frame: At weeks 8, 12 and 16 ]
  5. Number of patients experienced a worsening in symptom scores (SANDE) and/or NEI score ≥ 50% [ Time Frame: At week 4 ]
  6. Quality of life (IDEEL) questionnaire [ Time Frame: At weeks 4, 8, 12 and 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Dry Eye Disease (DED).
  3. Patients with severe Sjögren'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 >25 mm
    3. Schirmer test I (without anaesthesia) ≥2 ≤5mm/5min
  4. The same eye (eligible eye) must fulfill all the above criteria
  5. Patients diagnosed with severe Sjögren's dry eye disease at least 3 months before enrolment
  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.

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:

    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 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 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 in the last 2 years
  15. Any prior ocular surgery (including refractive, palpebral and cataract surgery) if within 90 days before the screening visit
  16. Participation in a clinical trial with a new active substance during the past 3 months
  17. Participation in another clinical trial study at the same time as the present study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05133180


Contacts
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Contact: Maria De Pizzol, PhD +39 02 583831 clinops@pec.dompe.it
Contact: Giovanna Di Turi, BSc clinops@pec.dompe.it

Locations
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United States, California
Lugene Eye Institute - Glendale Office Recruiting
Glendale, California, United States, 91204
David Wirta, M.D. & Associates Recruiting
Newport Beach, California, United States, 92663
United States, Maryland
The Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21218
United States, Massachusetts
Tufts University School of Medicine (TUSM) - New England Eye Center/Tufts Medical Center - Boston Recruiting
Boston, Massachusetts, United States, 02111
United States, Tennessee
Houston Eye Associates HEA - Gramercy Location Recruiting
Houston, Tennessee, United States, 77025
Toyos Clinic - Nashville Recruiting
Nashville, Tennessee, United States, 37215
United States, Virginia
Virginia Eye Consultants (VEC) - Norfolk Office Recruiting
Norfolk, Virginia, United States, 23502
Italy
AOU Gaspare Rodolico - Ospedale San Marco Recruiting
Catania, Italy, 95123
Contact: Teresio Avitabile, MD         
Università degli Studi "Gabriele D'Annunzio" - Ospedale SS. Annunziata - Clinica Oftalmologica Not yet recruiting
Chieti, Italy, 66100
Contact: Leonardo Mastropasqua, MD         
Università degli Studi di Milano - Ospedale San Giuseppe - UO Oculistica Not yet recruiting
Milan, Italy, 20123
Contact: Edoardo Villani, MD         
AOU Policlinico Umberto I - Dipartimento Organi di Senso - Clinica Oculistica Recruiting
Roma, Italy, 00161
Contact: Antonietta Moramarco, MD         
Sponsors and Collaborators
Dompé Farmaceutici S.p.A
Investigators
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Study Director: Francesco Sergio, MD Dompé Farmaceutici
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Responsible Party: Dompé Farmaceutici S.p.A
ClinicalTrials.gov Identifier: NCT05133180    
Other Study ID Numbers: NGF0121
2021-003346-21 ( EudraCT Number )
First Posted: November 24, 2021    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dompé Farmaceutici S.p.A:
Sjorgen's dry eye
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases