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

Phase 3CompletedNCT03419975

Taejoon Pharmaceutical Co., Ltd.146 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

146

Conditions

Primary Open-angle Glaucoma Ocular Hypertension

Interventions

TJO-002DRUG

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

LatanoprostDRUG

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

* 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

Locations (1)

Chan Yun, Kim

Seoul, South Korea

Outcomes

Primary Outcomes

Change From Baseline in diurnal IOP at Week 12

After 12 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on reducing diurnal IOP.

Time frame: Baseline and Week 12

Secondary Outcomes

Change From Baseline in diurnal IOP at Week 8

After 8 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on reducing diurnal IOP.

Time frame: Baseline and Week 8

Data from ClinicalTrials.gov

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