Primary Open-angle GlaucomaPhase 3NCT03419975
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 study testing TJO-002 and Latanoprost in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- TJO-002 and Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Apr 2016to 1 Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 19 or over
- Written informed consent to participate in the trial
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Primary Open-angle Glaucoma, Ocular Hypertension
- Being tested
- TJO-002, Latanoprost
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
LatanoprostDrug
Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye
| Study group | Role | What they receive |
|---|---|---|
| TJO-002 | Experimental | Not described Receives: Drug: TJO-002 |
| latanoprost | Active comparator | Not described Receives: Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start26 Apr 2016
- Primary completion28 Dec 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419975
- Sponsor's protocol ID
- TJO-002-301
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03419975
- Acronym / sponsor ID
- TJO-002-301
- Conditions
- Primary Open-angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TJO-002 | Experimental | Drug: TJO-002 |
| latanoprost | Active comparator | Drug: Latanoprost |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TJO-002Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye | Drug | TJO-002 |
| LatanoprostAdministrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye | Drug | latanoprost |
Primary outcome
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.
1 secondary outcome
Change From Baseline in diurnal IOP at Week 8
Time frame: Baseline and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TJO-002 and Latanoprost in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in diurnal IOP at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.