Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (NGF0121) (NGF0121)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05133180|
Recruitment Status : Recruiting
First Posted : November 24, 2021
Last Update Posted : April 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye||Drug: Oxervate Other: Vehicle||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||double-masked study|
|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|
one drop of cenegermin 20 mcg/mL will be instilled in both eyes three times daily.
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.
Vehicle will be instilled with the same scheme of the test product
Other Name: Reference product
- Schirmer I test (without anesthesia) >10mm/5min [ Time Frame: at week 4 ]in the eligible eye
- Change from baseline in Symptoms questionnaire (SANDE) global score [ Time Frame: at week 12 ]
- Change from baseline in Schirmer I test (without anesthesia) [ Time Frame: At weeks 4, 8, 12 and 16 ]
- 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 ]
- Change from baseline in Tear Film Break-Up Time (TFBUT) [ Time Frame: At weeks 4, 8, 12 and 16 ]
- Change from baseline in Symptoms questionnaire (SANDE) scores for severity and frequency [ Time Frame: At weeks 8, 12 and 16 ]
- Number of patients experienced a worsening in symptom scores (SANDE) and/or NEI score ≥ 50% [ Time Frame: At week 4 ]
- Quality of life (IDEEL) questionnaire [ Time Frame: At weeks 4, 8, 12 and 16 ]
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
|Contact: Maria De Pizzol, PhD||+39 02 email@example.com|
|Contact: Giovanna Di Turi, BScfirstname.lastname@example.org|
|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|
|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|
|Study Director:||Francesco Sergio, MD||Dompé Farmaceutici|