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

Sponsor

Taejoon Pharmaceutical Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04164459

Collaborator

(none)

144

Enrollment

Location

Arms

13.4

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Xalost S Drug: Xalatan Drug: Taflotan-S	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Dec 19, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Feb 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taejoon Pharmaceutical Co., Ltd.	Seoul		Korea, Republic of

Sponsors and Collaborators

Taejoon Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taejoon Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04164459

Other Study ID Numbers:

TJO-002-401

First Posted:

Nov 15, 2019

Last Update Posted:

Nov 15, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glaucoma

Latanoprost

Study Results

No Results Posted as of Nov 15, 2019