Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

NCT ID: NCT01568593

Last Updated: 2016-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

Brief Summary

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Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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T2750

Group Type EXPERIMENTAL

T2750

Intervention Type DEVICE

1 drop in each eye 3 to 6 times daily during 84 days

Vismed

Group Type ACTIVE_COMPARATOR

Vismed

Intervention Type DEVICE

1 drop in each eye 3 to 6 times daily during 84 days

Interventions

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T2750

1 drop in each eye 3 to 6 times daily during 84 days

Intervention Type DEVICE

Vismed

1 drop in each eye 3 to 6 times daily during 84 days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Signed and dated informed consent
* Male or female aged from ≥ 18 years old.
* Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.

Exclusion Criteria

* Best far corrected visual acuity \< 1/10
* Severe blepharitis
* Severe Dry Eye
* Eyelid malposition
* Known hypersensitivity to one of the components of the study medications or test products.
* Pregnant or breast-feeding woman.
* Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms).
* Inability of patient to understand the study procedures and thus inability to give informed consent.
* Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
* Already included once in this study.
* Patient under guardianship.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Paris, , France

Site Status

Countries

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France

Other Identifiers

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LT2750-PIII-10/11

Identifier Type: -

Identifier Source: org_study_id

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