rhNGF Eye Drops for Dry Eye Syndrome (REDUCO Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dompé Farmaceutici S.p.A

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the safety and efficacy of two different concentrations of the new formulation of rhNGF ophthalmic solution versus vehicle, in order to demonstrate superiority of at least one of the two concentrations over vehicle in the improvement of ocular symptoms of dry eye in participants with dry eye disease (DED). The rhNGF ophthalmic solution, or vehicle, will be administered as one drop in each eye, three times a day, for 4 weeks. Participants will attend a total of 5 study visits from screening through end of the study (Week 8), which will include eye exams and questionnaires.

Eligibility Criteria

This trial is for individuals with dry eye disease who can commit to a study schedule of 5 visits over 8 weeks. Participants will use the trial eye drops three times daily for 4 weeks.

Inclusion Criteria

I have been diagnosed with dry eye disease for over 6 months.

I have moderate-to-severe dry eye symptoms.

Exclusion Criteria

My eye condition is due to a lack of Vitamin A.

I have not had any unstable illnesses in the last month.

I need eye drops for another eye condition during the study.

I currently have an eye infection.

I have scarring in my eye from a specific condition.

I have severe eyelid inflammation.

I have had cancer within the last 3 years.

Treatment Details

The study tests two different strengths of a new rhNGF eye drop solution against a placebo. The goal is to see if either strength improves symptoms better than the placebo after being used in each eye, three times a day, for one month.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: IMP 2: rhNGF concentration 2Experimental Treatment1 Intervention

Investigational Medicinal Product (IMP) 2

Group II: IMP 1: rhNGF concentration 1Experimental Treatment1 Intervention

Investigational Medicinal Product (IMP) 1

Group III: Vehicle IMPPlacebo Group1 Intervention