NCT05136170

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives: * To compare the efficacy of cenegermin vs vehicle in Schirmer I test (without anaesthesia) \> 10 mm/5 min at Week 4 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in Symptom Assessment in Dry Eye questionnaire (SANDE) global score at Week 12 by testing the superiority. Secondary Objectives: * To compare the efficacy of cenegermin vs vehicle in Schirmer I test at Week 4, 8, 12 and 16 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in Cornea and conjunctiva vital staining with fluorescein (National Eye Institute \[NEI\] scales) at Week 4, 8, 12 and 16 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in Tear Film Break-Up Time (TFBUT) at Week 4, 8, 12 and 16 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in SANDE scores at Week 8, 12 and 16 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in worsening in symptom scores (SANDE) and/or NEI score at Week 4 by testing the superiority. * To compare the efficacy of cenegermin vs vehicle in impact of dry eye on everyday life (IDEEL) questionnaire at Week 4, 8, 12 and 16 by testing the superiority.

Detailed description

This was 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 under treatment with Ciclosporine A (or other drugs of the same class). During the Screening all procedures for inclusion and exclusion were performed. From the day of screening, the patients stopped any kind of further treatment, except CsA and commercially available preservative-free artificial tears provided by the Sponsor for a period of 8 days and 10 days as maximum. At the end of the washout period, patients still meeting the entry criteria for this study were randomized 1:1 and treated for 4 weeks with either cenegermin ophthalmic solution 20 mcg/mL three times a day (TID) or vehicle TID. In addition to topical CsA eye drops (both groups continued with topical CsA eye drops, or other topical ophthalmic treatment of the same class), during the 4 weeks of masked treatment, only the administration of investigational medicinal product (IMP) was allowed. During the follow up period, the patient could administer additional preservative-free artificial tear eye drops, provided by the Sponsor, only if strictly needed, and had to document in the patient's Diary the number of additional drops administered for each eye. Patients were then followed-up for efficacy and safety endpoints until Week 16 and for safety endpoints until Week 24. The total duration of the study was 25 weeks including 1 week of screening.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Cenegermin	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) for 28 consecutive days.
OTHER	Vehicle	Vehicle was instilled with the same scheme of the test product

Timeline

• Start date: 2022-01-27
• Primary completion: 2023-05-24
• Completion: 2023-05-24
• First posted: 2021-11-29
• Last updated: 2025-11-26
• Results posted: 2024-12-04

Locations

10 sites across 2 countries: United States, Italy

Regulatory

• FDA-regulated drug study