Glaucoma
Conditions
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.
Interventions
DRUGXalost S
One drop one times a day in study eye
DRUGXalatan
One drop one times a day in study eye
DRUGTaflotan-S
One drop one times a day in study eye
Sponsors
Taejoon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining Score at week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Hyperemia Score at week 4, 8, 12 | baseline and 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. |
| Change from baseline in Intraocular Pressure at week 4, 8, 12 | baseline and 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. |
Countries
South Korea
Contacts
Primary ContactSukyoung Kwon, PhD
Outcome results
None listed