A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase III Study to Evaluate the Efficacy and Safety of TJO-002 in POAG or Ocular Hypertension Patients

Taejoon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension; Primary Open-angle Glaucoma

Treatments: Drug: TJO-002; Drug: Latanoprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT03419975

TJO-002-301

Details and patient eligibility

About

TJO-002 or Acitve Control was administered on primary open-angle glaucoma or ocular hypertension patients for 12 weeks. This clinical trial study has hypothesize TJO-002 administration groups are not inferior to Active control administration groups.

Enrollment: 146 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

  • Male or female, age 19 or over
  • Written informed consent to participate in the trial

• Exclusion Criteria:

  • Any other Galucoma except POAG(ex, Closed anterior chamber angle, angle-closure glaucoma)
  • Any laser or ocular surgery within 3months prior screening
  • Use of contact lenses
  • Known reactive airways disease
  • 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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146 participants in 2 patient groups

TJO-002

Experimental group

Treatment:

Drug: TJO-002

latanoprost

Active Comparator group

Treatment:

Drug: Latanoprost