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

Ocular Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419975
• Other study ID #: TJO-002-301
• Status: Completed
• Phase: Phase 3
• Start date: April 26, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: January 2018
• Source: Taejoon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 1, 2018
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-angle Glaucoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Chan Yun, Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Taejoon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Week 12
Secondary	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.	Baseline and Week 8