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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

T

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

146 participants in 2 patient groups

TJO-002
Experimental group
Treatment:
Drug: TJO-002
latanoprost
Active Comparator group
Treatment:
Drug: Latanoprost

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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