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Idroflog® for Treatment of Dry Eye Disease (IDROFLOG)

NCT05724056 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-02-13

No results posted yet for this study

Summary

This study aims at demonstrating the non-inferiority of Idroflog compared to sodium hyaluronate 0.18% for the disease improvement of people with documented history of dry eyes and use of tear substitutes for at least 3 months.

Conditions

Interventions

DEVICE

Idroflog®

The study intervention posology will be based on current labeling of Idroflog®. Participants will be self-administering one drop in each eye 4 times a day every day during the study period. Administration should follow the label guidelines. Participants should detach a single vial from the strip, remove the flap at the top by rotating it and instill 1 drop into the conjunctival sac of each eye, dropping them from above.

DEVICE

Sodium Hyaluronate 0.18% (Vismed®)

The control intervention posology will be based on current labeling of Idroflog®. Participants will be self-administering one drop in each eye 4 times a day every day during the study period. Administration should follow the label guidelines. Participants should detach a single vial from the strip, remove the flap at the top by rotating it and instill 1 drop into the conjunctival sac of each eye, dropping them from above.

Sponsors & Collaborators

  • Alfa Intes Industria Terapeutica Splendore s.r.l.

    lead INDUSTRY

Principal Investigators

  • Marc LABETOULLE, Pr. · CHU Bicêtre, Service Ophtalmologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-10-01
Completion
2023-12-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT05724056 on ClinicalTrials.gov