Evaluating the Efficacy and Safety of Xalost S in Glaucoma Patients.

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase IV Study to Evaluate the Efficacy and Safety of Xalost S in Glaucoma Patients.

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Xalost S
* Drug: Xalatan
* Drug: Taflotan-S


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female diagnosed with glaucoma, age 19 or over Written informed consent to participate in the trial Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xalost S<br> | Drug: Xalost S<br>* One drop one times a day in study eye<br>|
| Active Comparator: Xalatan<br> | Drug: Xalatan<br>* One drop one times a day in study eye<br>|
| Active Comparator: Taflotan-S<br> | Drug: Taflotan-S<br>* One drop one times a day in study eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | baseline and week 4, 8, 12 |