REMOGEN® Omega Versus Cationorm® in the Treatment of Pati... | NCT03460548

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

NCT03460548

Sponsor

TRB Chemedica

Status

Terminated

Last Update Posted

Apr 20, 2020Actual

Enrollment

26Actual

Phase

Not Applicable

Conditions

Dry Eye

Interventions

Remogen
Cationorm

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low recruitment rate

Expanded Access Info

Start Date

Mar 30, 2018Actual

Primary Completion Date

Apr 16, 2019Actual

Completion Date

Jun 12, 2019Actual

First Submitted Date

Feb 28, 2018

First Submission Date that Met QC Criteria

Mar 7, 2018

First Posted Date

Mar 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2020

Last Update Posted Date

Apr 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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®.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Remogen	Experimental		Device: Remogen
Cationorm	Active Comparator		Device: Cationorm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remogen	Device	instil 1 drop of the product in each eye, 4 times per day	Remogen

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christophe Baudouin, MD, PhD	Quinze-Vingts Hospital, Paris, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Quinze-Vingts Hospital		Paris			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided