Efficacy of T2259 in DED

NCT ID: NCT03874429

Last Updated: 2023-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2021-03-25

Brief Summary

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The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

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
investigator-masked

Study Groups

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T2259

1 drop in each eye 2 to 4 times daily

Group Type EXPERIMENTAL

T2259

Intervention Type DEVICE

Sodium Hyaluronate and Trehalose

Vismed Multi

1 drop in each eye 2 to 4 times daily

Group Type ACTIVE_COMPARATOR

Vismed multi

Intervention Type DEVICE

HA

Interventions

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T2259

Sodium Hyaluronate and Trehalose

Intervention Type DEVICE

Vismed multi

HA

Intervention Type DEVICE

Other Intervention Names

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Sodium Hyaluronate and Trehalose Sodium Hyaluronate

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

* Far best-corrected visual acuity≤2/10
* Severe Blepharitis
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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C.H.N.O des XV-XX

Paris, , France

Site Status

Countries

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France

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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LT2259-001

Identifier Type: -

Identifier Source: org_study_id

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