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

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Xalost S
Xalatan
Taflotan-S
Sponsored by
Taejoon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taejoon Pharmaceutical Co., Ltd.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Xalost S

Xalatan

Taflotan-S

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 15, 2019
Last Updated
November 14, 2019
Sponsor
Taejoon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04164459
Brief Title
Evaluating the Efficacy and Safety of Xalost S in Glaucoma Patients.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taejoon Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xalost S
Arm Type
Experimental
Arm Title
Xalatan
Arm Type
Active Comparator
Arm Title
Taflotan-S
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Xalost S
Intervention Description
One drop one times a day in study eye
Intervention Type
Drug
Intervention Name(s)
Xalatan
Intervention Description
One drop one times a day in study eye
Intervention Type
Drug
Intervention Name(s)
Taflotan-S
Intervention Description
One drop one times a day in study eye
Primary Outcome Measure Information:
Title
Corneal Staining Score at week 12
Description
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.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Change from baseline in Hyperemia Score at week 4, 8, 12
Description
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.
Time Frame
baseline and week 4, 8, 12
Title
Change from baseline in Intraocular Pressure at week 4, 8, 12
Description
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.
Time Frame
baseline and week 4, 8, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sukyoung Kwon, PhD
Phone
+82-2-799-0175
Email
skkwon@taejoon.co.kr
Facility Information:
Facility Name
Taejoon Pharmaceutical Co., Ltd.
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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