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Biological

IMP 2: rhNGF concentration 2 for Dry Eye Syndrome (REDUCO Trial)

Phase 2
Recruiting
Research Sponsored by Dompé Farmaceutici S.p.A
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of dry eye disease at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye)
Moderate-to-severe dry eye characterized by specific clinical features
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights

REDUCO Trial Summary

This trial aims to test the safety and effectiveness of two different strengths of a new eye drop solution compared to a placebo, in treating dry eye disease. Participants will use the eye drops three times a day

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not specified here but may include irritation at the site of application, allergic reactions, or other ocular discomforts typically associated with eye drops.

REDUCO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with dry eye disease for over 6 months.
Select...
I have moderate-to-severe dry eye symptoms.

REDUCO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline to Week 8 in symptoms of dry eye assessed by SANDE Global Score
Secondary outcome measures
Change from baseline in the proportion of participants with vitritis, retinal or vitreal hemorrhages, increase in cup-to-disc ratio, retinal or posterior vitreal detachment, retinal tears, or maculopathy on dilated fundus exam (DFE) in both eyes
Incidence and frequency of Treatment-Emergent Adverse Events (TEAEs) assessed throughout the study including Run-In period
Mean change from baseline as assessed by the OPAS questionnaire QoL scores
+12 more

REDUCO Trial Design

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

Find a Location

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
49 Previous Clinical Trials
4,243 Total Patients Enrolled
Flavio Mantelli, MD, PhDStudy DirectorDompé Farmaceutici S.p.A
6 Previous Clinical Trials
463 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals enrolled in this clinical research study?

"A total of 291 eligible participants are required to facilitate this research investigation. The sponsor, Dompé Farmaceutici S.p.A., will oversee the trial at various locations such as Toyos Clinic in Nashville, Tennessee and New England Eye Center - Boston in Boston, Massachusetts."

Answered by AI

At how many distinct sites is this medical study currently being conducted?

"This study is ongoing at 14 different locations, with sites situated in various cities such as Nashville, Boston, and Baltimore among others. Opting for the nearest site to your residence can reduce travel obligations if you decide to enroll."

Answered by AI

Is it presently possible for individuals to enroll in this clinical trial?

"Indeed, the details available on clinicaltrials.gov indicate that this investigation is currently seeking volunteers. Originally shared on 1/22/2024 and most recently revised on 1/29/2024, the research aims to recruit a total of 291 individuals from 14 distinct locations."

Answered by AI

What are the risks associated with IMP 1: rhNGF concentration 1 for individuals undergoing treatment?

"The safety assessment for IMP 1: rhNGF concentration 1 is rated at 2 by our team due to being a Phase 2 trial. While there is existing data supporting its safety profile, evidence of efficacy is yet to be established."

Answered by AI

Who else is applying?

What site did they apply to?
Arizona Eye Center
East West Eye Institute
Sibia Eye Institute
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

HAD DRY EYES FOREVER.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Safety and Efficacy of a New Formulation of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution in Patients With Dry Eye Disease
2024. "A Study to Evaluate Safety and Efficacy of a New Formulation of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution in Patients With Dry Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06244316.
All > Paid Studies Boston > Colorado Springs
~166 spots leftby Sep 2024
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