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

Phase 4

• Conditions: Glaucoma
• Interventions: Drug: Xalatan; Drug: Taflotan-S; Drug: Xalost S

• Registration Number: NCT04164459
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-19
• Status Verified: 2019-09
• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-11-14
• Last Update Submitted: 2019-11-14
• Study First Posted: 2019-11-15
• Last Update Posted: 2019-11-15
• Primary Completion: 2019-12
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xalatan	Xalatan	-
Taflotan-S	Taflotan-S	-
Xalost S	Xalost S	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Taejoon Pharmaceutical Co., Ltd.; 🇰🇷 Seoul, Korea, Republic of