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Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hyaluronic Acid 0.3% (FBV_01) vs Hyaluronic Acid 0.3% in Subjects in the Treatment From Moderate to Severe DED

NCT07412860 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-02-17

No results posted yet for this study

Summary

The goal of this clinical investigation plan is to evaluate the performance, tolerability, safety, and compliance of an ophthalmic solution containing an ancillary medicinal substance and hyaluronic acid 0.3% (FBV\_01) compared with hyaluronic acid 0.3% alone in adult men and women (≥18 years) with moderate-to-severe dry eye syndrome.

The main questions it aims to answer are:

* Is the ophthalmic solution containing an ancillary medicinal substance and hyaluronic acid non-inferior in improving the clinical performance outcomes of dry eye compared with hyaluronic acid alone?
* Is the investigational device safe and well tolerated, with acceptable partecipant compliance over the treatment period?

Researchers will compare the medical device containing an ancillary medicinal substance and hyaluronic acid 0.3% (FBV\_01) to hyaluronic acid 0.3% alone to see if the combination provides at least equivalent clinical benefit without increased safety issues.

Participants will be randomly assigned (1:1) to one of two treatment groups in a multicenter, prospective, randomized, open-label, controlled study. Participants will instill 1 drop in both eyes 4 times daily (every 4 ± 1 hours) for 30 ± 4 days and attend study visits for assessments of dry eye signs and symptoms, safety, tolerability, and treatment compliance. The study plans to enroll 74 partecipants, with an enrollment period of about 11 months and a total study duration of approximately 12 months (from first partecipant first visit to last partecipant last visit).

Conditions

  • Dry Eye Syndromes
  • Dry Eye Disease (DED)

Interventions

DEVICE

FBV_01

Instill one drop into the conjunctival fornix four times a day.

DEVICE

HYLO-VISION® SafeDrop® Gel

Instill one drop into the conjunctival fornix four times a day.

Sponsors & Collaborators

  • FB Vision S.p.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07412860 on ClinicalTrials.gov