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

NCT ID: NCT04164459

Last Updated: 2019-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2020-02-29

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.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Xalost S

Group Type EXPERIMENTAL

Xalost S

Intervention Type DRUG

One drop one times a day in study eye

Xalatan

Group Type ACTIVE_COMPARATOR

Xalatan

Intervention Type DRUG

One drop one times a day in study eye

Taflotan-S

Group Type ACTIVE_COMPARATOR

Taflotan-S

Intervention Type DRUG

One drop one times a day in study eye

Interventions

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Xalost S

One drop one times a day in study eye

Intervention Type DRUG

Xalatan

One drop one times a day in study eye

Intervention Type DRUG

Taflotan-S

One drop one times a day in study eye

Intervention Type DRUG

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taejoon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taejoon Pharmaceutical Co., Ltd.

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sukyoung Kwon, PhD

Role: CONTACT

+82-2-799-0175

Other Identifiers

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TJO-002-401

Identifier Type: -

Identifier Source: org_study_id

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