REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye

April 16, 2020 updated by: TRB Chemedica

A Multicentre Randomized Trial Comparing the Efficacy and Safety of REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye

The efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will be investigated in comparison to Cationorm®.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Quinze-Vingts Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • With at least a 3-month documented history of bilateral dry eye
  • With a score of ocular surface staining with fluorescein (OSSF) ≥ 4 and ≤ 9 on the Oxford scale
  • With at least one objective sign of tear deficiency
  • With Ocular Surface Disease Index (OSDI) score of ≥ 18

Exclusion Criteria:

  • Refractive surgery within 12 months prior to selection
  • Any other ocular surgery or ocular trauma within 6 months prior to selection
  • Systemic or local use of one of the following medications: glucocorticosteroids, cyclosporine A, antibiotics, NSAIDs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Remogen
Device: Remogen
instil 1 drop of the product in each eye, 4 times per day
ACTIVE_COMPARATOR: Cationorm
Device: Cationorm
instil 1 drop of the product in each eye, 4 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSSF
Time Frame: Day 28
Ocular surface staining with fluorescein (OSSF)
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TRB Chemedica

Investigators

  • Principal Investigator: Christophe Baudouin, MD, PhD, Quinze-Vingts Hospital, Paris, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 30, 2018

Primary Completion (ACTUAL)

April 16, 2019

Study Completion (ACTUAL)

June 12, 2019

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (ACTUAL)

March 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOGA-CT-1501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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