Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients

NCT ID: NCT03825380

Last Updated: 2023-11-21

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

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-23

Study Completion Date

2021-02-24

Brief Summary

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The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.

Detailed Description

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Conditions

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Ocular Hypertension 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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T4032

Group Type EXPERIMENTAL

Bimatoprost

Intervention Type DRUG

Eyedrops

Lumigan®

Group Type ACTIVE_COMPARATOR

Lumigan®

Intervention Type DRUG

Eyedrops

Interventions

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Bimatoprost

Eyedrops

Intervention Type DRUG

Lumigan®

Eyedrops

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent signed and dated.
* Both eyes with diagnosed open-angle glaucoma or ocular hypertension

Exclusion Criteria

* History of trauma, infection, clinically significant inflammation within the 3 previous months.
* Uncontrolled diabetic patient.
* Pregnancy or breast feeding.
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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Hospital

Tallinn, , Estonia

Site Status

Countries

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Estonia

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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LT4032-301

Identifier Type: -

Identifier Source: org_study_id

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