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OpenTrials
Completed

NCT Number: NCT03419975

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

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.

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Key information

Conditions

Primary Open-Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chan Yun, Kim

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

TJO-002

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

Drug

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

Primary outcomes

  1. Change From Baseline in diurnal IOP at Week 12

    Time frame: 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 outcomes

  1. Change From Baseline in diurnal IOP at Week 8

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taejoon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 5, 2018
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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