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

Glaucoma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164459
• Other study ID #: TJO-002-401
• Status: Recruiting
• Phase: Phase 4
• Start date: December 19, 2018
• Est. completion date: February 2020

Study information

• Verified date: September 2019
• Source: Taejoon Pharmaceutical Co., Ltd.
• Contact: Sukyoung Kwon, PhD
• Phone: +82-2-799-0175
• Email: skkwon[@]taejoon.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Xalost S
One drop one times a day in study eye
• Xalatan
One drop one times a day in study eye
• Taflotan-S
One drop one times a day in study eye

Locations

Country	Name	City	State
Korea, Republic of	Taejoon Pharmaceutical Co., Ltd.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Taejoon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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