Back to resultsREMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
Primary Purpose
Dry Eye
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Remogen
Cationorm
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
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
Sites / Locations
- Quinze-Vingts Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remogen
Cationorm
Arm Description
Outcomes
Primary Outcome Measures
OSSF
Ocular surface staining with fluorescein (OSSF)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03460548
Brief Title
REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
Official Title
A Multicentre Randomized Trial Comparing the Efficacy and Safety of REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
low recruitment rate
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
June 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TRB Chemedica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remogen
Arm Type
Experimental
Arm Title
Cationorm
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Remogen
Intervention Description
instil 1 drop of the product in each eye, 4 times per day
Intervention Type
Device
Intervention Name(s)
Cationorm
Intervention Description
instil 1 drop of the product in each eye, 4 times per day
Primary Outcome Measure Information:
Title
OSSF
Description
Ocular surface staining with fluorescein (OSSF)
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Baudouin, MD, PhD
Organizational Affiliation
Quinze-Vingts Hospital, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quinze-Vingts Hospital
City
Paris
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
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