Status:
TERMINATED
REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
Lead Sponsor:
TRB Chemedica
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
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®.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2019
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03460548
Start Date
March 30 2018
End Date
June 12 2019
Last Update
April 20 2020
Active Locations (1)
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1
Quinze-Vingts Hospital
Paris, France