Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients

NCT ID: NCT01156012

Last Updated: 2015-01-22

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

PHASE3

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.

Detailed Description

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Conditions

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Glaucoma

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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T2345

One drop of T2345

Group Type EXPERIMENTAL

T2345

Intervention Type DRUG

One drop of T2345

Prostaglandin

One drop

Group Type ACTIVE_COMPARATOR

Prostaglandin

Intervention Type DRUG

One drop

Interventions

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T2345

One drop of T2345

Intervention Type DRUG

Prostaglandin

One drop

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients diagnosed with glaucoma

Exclusion Criteria

* Under 18.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 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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Medical Director

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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2009-011157-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LT2345-PIII-12/08

Identifier Type: -

Identifier Source: org_study_id

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