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

November 14, 2019 updated by: Taejoon Pharmaceutical Co., Ltd.

A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase IV Study to Evaluate the Efficacy and Safety of Xalost S in Glaucoma Patients.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Taejoon Pharmaceutical Co., Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xalost S
Drug: Xalost S
One drop one times a day in study eye
Active Comparator: Xalatan
Drug: Xalatan
One drop one times a day in study eye
Active Comparator: Taflotan-S
Drug: Taflotan-S
One drop one times a day in study eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal Staining Score at week 12
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Hyperemia Score at week 4, 8, 12
Time Frame: 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.
baseline and week 4, 8, 12
Change from baseline in Intraocular Pressure at week 4, 8, 12
Time Frame: 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.
baseline and week 4, 8, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taejoon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

October 15, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJO-002-401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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