NCT03419975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 4, 2019

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

January 24, 2018

Last Update Submit

September 2, 2019

Conditions

Primary Open-angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change From Baseline in diurnal IOP at Week 8

    Baseline and Week 8

Study Arms (2)

TJO-002

EXPERIMENTAL
Drug: TJO-002

latanoprost

ACTIVE COMPARATOR
Drug: Latanoprost

Interventions

TJO-002DRUG

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

TJO-002
LatanoprostDRUG

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

latanoprost

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age 19 or over
  • Written informed consent to participate in the trial

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chan Yun, Kim

Seoul, South Korea

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 5, 2018

Study Start

April 26, 2016

Primary Completion

December 28, 2017

Study Completion

June 1, 2018

Last Updated

September 4, 2019

Record last verified: 2018-01

Locations

KR(1)