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

Not Applicable

Terminated

• Conditions: Dry Eye
• Interventions: Device: Remogen; Device: Cationorm

• Registration Number: NCT03460548
• Lead Sponsor: TRB Chemedica

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 available

Study Timeline

• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-09
• Study Start: 2018-03-30
• Primary Completion: 2019-04-16
• Study Completion: 2019-06-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remogen	Remogen	-
Cationorm	Cationorm	-

Primary Outcome Measures

Name	Time	Method
OSSF	Day 28	Ocular surface staining with fluorescein (OSSF)

Trial Locations

Locations (1)

Quinze-Vingts Hospital; 🇫🇷 Paris, France