Evaluating the Efficacy and Safety of Xalost S in Glaucoma Patients.
A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase IV Study to Evaluate the Efficacy and Safety of Xalost S in Glaucoma Patients.
1 other identifier
interventional
144
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2018
CompletedFirst Submitted
Initial submission to the registry
October 15, 2019
CompletedFirst Posted
Study publicly available on registry
November 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedNovember 15, 2019
September 1, 2019
12 months
October 15, 2019
November 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
week 12
Secondary Outcomes (2)
Change from baseline in Hyperemia Score at week 4, 8, 12
baseline and week 4, 8, 12
Change from baseline in Intraocular Pressure at week 4, 8, 12
baseline and week 4, 8, 12
Study Arms (3)
Xalost S
EXPERIMENTALXalatan
ACTIVE COMPARATORTaflotan-S
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female diagnosed with glaucoma, age 19 or over
- Written informed consent to participate in the trial
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taejoon Pharmaceutical Co., Ltd.
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2019
First Posted
November 15, 2019
Study Start
December 19, 2018
Primary Completion
December 1, 2019
Study Completion
February 1, 2020
Last Updated
November 15, 2019
Record last verified: 2019-09