ClinicalTrials.gg
CompletedNCT03419975Updated Sep 4, 2019

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

A Phase 3 interventional study of TJO-002 and Latanoprost in Primary Open-angle Glaucoma and Ocular Hypertension, sponsored by Taejoon Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-09-04.

Sponsored by Taejoon Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Apr 2016, registered Jan 2018).

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Phase
Phase 3
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 21 studies in Glaucoma, Open-Angle with a site in Korea, Republic of — 3 open to participants now, 3 under way, 2 of them phase 3. Glaucoma, Open-Angle · Korea, Republic of.

Planned enrollment
9th of 15
146 · median 150
Started
2016
with 1 other
Phase 3
7 of 21
2 open now
Registered
13th of 21
by date

Among the 21 studies in Glaucoma, Open-Angle with a site in Korea, Republic of, this one is the 9th largest by planned enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2016, is one of 7 in phase 3, and was the 13th registered.

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 116 are open to participants now.

Browse Glaucoma, Open-Angle studies →

Open to participants now

3 of the 21 studies in Glaucoma, Open-Angle with a site in Korea, Republic of are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 83 Glaucoma, Open-Angle studies recruiting now, 64 (77%) set no upper age limit and 5 (6%) stop at 75 or younger; 5 take children under 18; 11 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 21 studies in Glaucoma, Open-Angle with a site in Korea, Republic of, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Primary Open-angle Glaucoma
  • Ocular Hypertension
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female, age 19 or over

    • Written 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
146 participants (estimated)

Study arms

  • Experimental
    TJO-002

    Drug: TJO-002

  • Active comparator
    latanoprost

    Drug: Latanoprost

Interventions

  • DrugTJO-002

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

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

06

What researchers measure

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.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 8

07

Study locations

1 site
  • Chan Yun, Kim
    Seoul, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2016 to primary completion in Dec 2017, 20 months.

Of 47 industry-sponsored phase 3 interventional studies under Glaucoma, Open-Angle, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's 20 months is below that.

Counting every sponsor, half of 49 studies reached it within 25 months; a quarter within 12 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2018
First posted
Feb 5, 2018
StartActual
Apr 26, 2016
Primary completionActual
Dec 28, 2017
CompletionActual
Jun 1, 2018
Last update
Sep 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03419975
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Apr 26, 2016
Primary completion
Dec 28, 2017
Completion
Jun 1, 2018
Last update
Sep 4, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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