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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03419975

Enrollment

146

Registered

2018-02-05

Start date

2016-04-26

Completion date

2018-06-01

Last updated

2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Primary Open-angle Glaucoma

Brief summary

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.

Interventions

DRUGTJO-002

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

DRUGLatanoprost

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in diurnal IOP at Week 12	Baseline and 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.

Secondary

Measure	Time frame	Description
Change From Baseline in diurnal IOP at Week 8	Baseline and 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026