Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study)

(NGF0121 Trial)

Recruiting at11 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Dompé Farmaceutici S.p.A

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests cenegermin eye drops in patients with severe Sjogren's dry eye disease. Cenegermin helps heal the eye's surface, potentially improving dry eye symptoms. The study compares its effectiveness to another treatment over a period of time. Cenegermin is a recombinant human nerve growth factor that has been found to be safe and well tolerated.

Research Team

Flavio Mantelli, MD

Principal Investigator

Dompé Farmaceutici

Eligibility Criteria

Inclusion Criteria

Males of reproductive potential should use effective contraception during treatment and 30 days after the study treatment period

Male or female aged ≥ 18 years

- The same eye (eligible eye) must fulfill all the above criteria

Exclusion Criteria

Presence of any other ocular disorder or condition requiring topical medication during the entire duration of study in either eye

Intraocular inflammation defined as Tyndall score >0

You have had cancer in the past 5 years.

Treatment Details

Interventions

• Cenegermin (Oxervate) (Growth Factor)

Participant Groups

Group I: Oxervate Experimental Treatment 1 Intervention

One drop of cenegermin 20 mcg/mL (rhNGF 20 mcg/mL) in the pharmaceutical form of ophthalmic sterile solution was instilled in both eyes three times daily (TID), every six hours.

Group II: Vehicle Placebo Group 1 Intervention

One drop of vehicle ophthalmic solution was instilled in both eyes TID (every six hours).

Who Is Running the Clinical Trial?

Dompé Farmaceutici S.p.A

Lead Sponsor

Trials

53

Recruited

4,400+

Founded

:[-1880s implied start, exact date not specified],