A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase III Study to Evaluate the Efficacy and Safety of TJO-002 in POAG or Ocular Hypertension Patients

NCT ID: NCT03419975

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-26

Study Completion Date

2018-06-01

Brief Summary

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TJO-002 or Acitve Control was administered on primary open-angle glaucoma or ocular hypertension patients for 12 weeks. This clinical trial study has hypothesize TJO-002 administration groups are not inferior to Active control administration groups.

Detailed Description

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Conditions

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Primary Open-angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TJO-002

Group Type EXPERIMENTAL

TJO-002

Intervention Type DRUG

Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye

latanoprost

Group Type ACTIVE_COMPARATOR

Latanoprost

Intervention Type DRUG

Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye

Interventions

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TJO-002

Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye

Intervention Type DRUG

Latanoprost

Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, age 19 or over
* Written informed consent to participate in the trial

Exclusion Criteria

* Any other Galucoma except POAG(ex, Closed anterior chamber angle, angle-closure glaucoma)
* Any laser or ocular surgery within 3months prior screening
* Use of contact lenses
* Known reactive airways disease
* Any condition limiting patient's ability to participate in the trial
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taejoon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chan Yun, Kim

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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TJO-002-301

Identifier Type: -

Identifier Source: org_study_id

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