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

A Multicentre Randomized Trial Comparing the Efficacy and Safety of REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03460548

Enrollment

Registered

2018-03-09

Start date

2018-03-30

Completion date

2019-06-12

Last updated

2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

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®.

Interventions

DEVICERemogen

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

DEVICECationorm

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026