Back to resultsA 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
Primary Purpose
Primary Open-angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TJO-002
Latanoprost
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open-angle Glaucoma
Eligibility 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
Sites / Locations
- Chan Yun, Kim
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TJO-002
latanoprost
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03419975
First Posted
January 24, 2018
Last Updated
September 2, 2019
Sponsor
Taejoon Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03419975
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 26, 2016 (Actual)
Primary Completion Date
December 28, 2017 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taejoon Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TJO-002
Arm Type
Experimental
Arm Title
latanoprost
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
TJO-002
Intervention Description
Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Intervention Description
Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye
Primary Outcome Measure Information:
Title
Change From Baseline in diurnal IOP at Week 12
Description
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 Outcome Measure Information:
Title
Change From Baseline in diurnal IOP at Week 8
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chan Yun, Kim
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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
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