GlaucomaPhase 4NCT04164459
Evaluating the Efficacy and Safety of Xalost S in Glaucoma Patients.
A Phase 4 study testing Xalost S, Xalatan and Taflotan-S in people with Glaucoma, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
In patients with Glaucoma, Xalost S or Xalatan or Taflotan-S are administered for 12 weeks. After 12 weeks, among them, Xalatan administration group are switched to Xalost S or Taflotan-S. Extension study period is 8 weeks. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Xalost S, Xalatan and Taflotan-S
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Dec 2018to Feb 2020
- Phase
- Phase 4
- 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 diagnosed with glaucoma, age 19 or over
- Written informed consent to participate in the trial
Who cannot join
- Patients who have received or have plans lacrimal puntual occulsion
- Use of contact lenses
- Any other Glaucoma except primary open angle glaucoma/normal tension glaucoma (ex) Closed anterior chamber angle/ angle-closure Glaucoma)
- Any condition limiting patient's ability to participate in the trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Taejoon Pharmaceutical Co., Ltd.
Seoul
About this study
Official title: A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase IV Study to Evaluate the Efficacy and Safety of Xalost S in Glaucoma Patients.
In patients with Glaucoma, Xalost S or Xalatan or Taflotan-S are administered for 12 weeks. After 12 weeks, among them, Xalatan administration group are switched to Xalost S or Taflotan-S. Extension study period is 8 weeks.
To compare effect (ocular surface damage) and safety of preservative-free Latanoprost/Tafluprost to Benzalkonium chloride-preserved Latanoprost in primary open angle glaucoma or normal tension glaucoma.
- Conditions
- Glaucoma
- Being tested
- Xalost S, Xalatan, Taflotan-S
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xalost SDrug
One drop one times a day in study eye
XalatanDrug
One drop one times a day in study eye
Taflotan-SDrug
One drop one times a day in study eye
| Study group | Role | What they receive |
|---|---|---|
| Xalost S | Experimental | Not described Receives: Drug: Xalost S |
| Xalatan | Active comparator | Not described Receives: Drug: Xalatan |
| Taflotan-S | Active comparator | Not described Receives: Drug: Taflotan-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Staining Score at week 12
At week 12 of drug administration compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on corneal staining score.
Scale: "Oxford grading system" that divides into 6 groups according to severity from 0 (absent) to 5 (severe).
The higher scores mean a worse outcome.
Measured: week 12
Secondary outcomes (2)
Change from baseline in Hyperemia Score at week 4, 8, 12
After 4, 8, 12 weeks of drug administration compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on Hyperemia Score.
Scale: "Efron Grading Scales" that divided into 5 groups according to severity from 0 (normal) to 4 (severe).
The higher scores mean a worse outcome.
Measured: baseline and week 4, 8, 12
Change from baseline in Intraocular Pressure at week 4, 8, 12
After 4, 8, 12 weeks of drug administration compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on Intraocular pressure.
The highest Intraocular pressure means a worse outcome.
Measured: baseline and week 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start19 Dec 2018
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 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
- NCT04164459
- Sponsor's protocol ID
- TJO-002-401
- Status last verified
- Sep 2019
- First submitted
- 15 Oct 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 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 IV Study to Evaluate the Efficacy and Safety of Xalost S in Glaucoma Patients.
- ClinicalTrials.gov ID
- NCT04164459
- Acronym / sponsor ID
- TJO-002-401
- Conditions
- Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 15 Nov 2019 (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.
In patients with Glaucoma, Xalost S or Xalatan or Taflotan-S are administered for 12 weeks. After 12 weeks, among them, Xalatan administration group are switched to Xalost S or Taflotan-S. Extension study period is 8 weeks.
To compare effect (ocular surface damage) and safety of preservative-free Latanoprost/Tafluprost to Benzalkonium chloride-preserved Latanoprost in primary open angle glaucoma or normal tension glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xalost S | Experimental | Drug: Xalost S |
| Xalatan | Active comparator | Drug: Xalatan |
| Taflotan-S | Active comparator | Drug: Taflotan-S |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female diagnosed with glaucoma, age 19 or over
- Written informed consent to participate in the trial
Key exclusion criteria (4 listed)
- Patients who have received or have plans lacrimal puntual occulsion
- Use of contact lenses
- Any other Glaucoma except primary open angle glaucoma/normal tension glaucoma (ex) Closed anterior chamber angle/ angle-closure Glaucoma)
- Any condition limiting patient's ability to participate in the trial
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 |
|---|---|---|
| Xalost SOne drop one times a day in study eye | Drug | Xalost S |
| XalatanOne drop one times a day in study eye | Drug | Xalatan |
| Taflotan-SOne drop one times a day in study eye | Drug | Taflotan-S |
Primary outcome
Corneal Staining Score at week 12
Time frame: week 12
At week 12 of drug administration compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on corneal staining score. Scale: "Oxford grading system" that divides into 6 groups according to severity from 0 (absent) to 5 (severe). The higher scores mean a worse outcome.
2 secondary outcomes
Change from baseline in Hyperemia Score at week 4, 8, 12
Time frame: baseline and week 4, 8, 12
Change from baseline in Intraocular Pressure at week 4, 8, 12
Time frame: baseline and week 4, 8, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xalost S, Xalatan and Taflotan-S in people with Glaucoma, 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 4 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: status not confirmed, as of the sponsor's last update on 15 Nov 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sukyoung Kwon, PhD (+82-2-799-0175, skkwon@taejoon.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Staining Score at week 12 (time frame: 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 15 Nov 2019.