Efficacy, Safety of T2769 in Dry Eye Disease

NCT ID: NCT03830359

Last Updated: 2022-03-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-02-18

Brief Summary

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Efficacy of T2769 in Dry Eye Desease

Detailed Description

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Multicenter and open study

Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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T2769

T2769 Ophthalmic solution patients treated with 1 drop in each eye 3 to 6 times daily

Group Type EXPERIMENTAL

T2769

Intervention Type OTHER

At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days

Interventions

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T2769

At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days

Intervention Type OTHER

Other Intervention Names

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Ophthalmic solution

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 screening

Exclusion Criteria

* Best far corrected visual acuity ≤ 2/10
* Severe blepharitis Severe dry eye
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

Principal Investigators

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Lamia El Fekih, Pr

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Hôpital Universitaire Tahar Sfar

Mahdia, , Tunisia

Site Status

"Hôpital Universitaire Fattouma Bourguiba

Monastir, , Tunisia

Site Status

"Hôpital de Forces de Sécurité Intérieure La Marsa

Tunis, , Tunisia

Site Status

Countries

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Tunisia

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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LT2769-001

Identifier Type: -

Identifier Source: org_study_id

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