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

NCT ID: NCT03460548

Last Updated: 2020-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2019-06-12

Brief Summary

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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

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Remogen

Group Type EXPERIMENTAL

Remogen

Intervention Type DEVICE

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

Cationorm

Group Type ACTIVE_COMPARATOR

Cationorm

Intervention Type DEVICE

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

Interventions

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Remogen

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

Intervention Type DEVICE

Cationorm

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TRB Chemedica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe Baudouin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Quinze-Vingts Hospital, Paris, France

Locations

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Quinze-Vingts Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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TOGA-CT-1501

Identifier Type: -

Identifier Source: org_study_id

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