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

Taejoon Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Glaucoma

Treatments: Drug: Xalost S; Drug: Taflotan-S; Drug: Xalatan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04164459

TJO-002-401

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 3 patient groups

Xalost S

Experimental group

Treatment:

Drug: Xalost S

Xalatan

Active Comparator group

Treatment:

Drug: Xalatan

Taflotan-S

Active Comparator group

Treatment:

Drug: Taflotan-S