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Biological

rhNGF Eye Drops 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
Must not have
Destruction of conjunctival goblet cells such as in Vitamin A deficiency
Unstable systemic disease within 1 month before screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My eye condition is due to a lack of Vitamin A.
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I have not had any unstable illnesses in the last month.
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I need eye drops for another eye condition during the study.
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I currently have an eye infection.
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I have scarring in my eye from a specific condition.
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I have severe eyelid inflammation.
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I have had cancer within the last 3 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change from baseline to Week 8 in symptoms of dry eye assessed by SANDE Global Score
Secondary study objectives
Mean change from baseline as assessed by the OPAS questionnaire QoL scores
Mean change from baseline in BCDVA score
Mean change from baseline in Schirmer- I score without anesthesia in the Study Eye
+8 more

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

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Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
51 Previous Clinical Trials
4,287 Total Patients Enrolled
Flavio Mantelli, MD, PhDStudy DirectorDompé Farmaceutici S.p.A
6 Previous Clinical Trials
450 Total Patients Enrolled
~166 spots leftby Nov 2025
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