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 3

Completed

• Conditions: Primary Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: TJO-002; Drug: Latanoprost

• Registration Number: NCT03419975
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-26
• Primary Completion: 2017-12-28
• Status Verified: 2018-01
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-05
• Study Completion: 2018-06-01
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TJO-002	TJO-002	-
latanoprost	Latanoprost	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chan Yun, Kim; 🇰🇷 Seoul, Korea, Republic of