NCT03460548

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

March 30, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

February 28, 2018

Last Update Submit

April 16, 2020

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • OSSF

    Ocular surface staining with fluorescein (OSSF)

    Day 28

Study Arms (2)

Remogen

EXPERIMENTAL
Device: Remogen

Cationorm

ACTIVE COMPARATOR
Device: Cationorm

Interventions

RemogenDEVICE

instil 1 drop of the product in each eye, 4 times per day

Remogen
CationormDEVICE

instil 1 drop of the product in each eye, 4 times per day

Cationorm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quinze-Vingts Hospital

Paris, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Christophe Baudouin, MD, PhD

    Quinze-Vingts Hospital, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 9, 2018

Study Start

March 30, 2018

Primary Completion

April 16, 2019

Study Completion

June 12, 2019

Last Updated

April 20, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)