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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

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ClinicalTrials.gov Identifier: NCT03419975
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Taejoon Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma Ocular Hypertension Drug: TJO-002 Drug: Latanoprost Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 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 III Study to Evaluate the Efficacy and Safety of TJO-002 in Primary Open Angle Glaucoma or Ocular Hypertension Patients
Actual Study Start Date : April 26, 2016
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: TJO-002 Drug: TJO-002
Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye

Active Comparator: latanoprost Drug: Latanoprost
Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye




Primary Outcome Measures :
  1. Change From Baseline in diurnal IOP at Week 12 [ Time Frame: Baseline and Week 12 ]
    After 12 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on reducing diurnal IOP.


Secondary Outcome Measures :
  1. Change From Baseline in diurnal IOP at Week 8 [ Time Frame: Baseline and Week 8 ]
    After 8 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on reducing diurnal IOP.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419975


Contacts
Contact: Chan Yun Kim, M.D., PhD 82-2-361-8452

Locations
Korea, Republic of
Chan Yun, Kim Recruiting
Seoul, Korea, Republic of
Contact: Chan Yun Kim, MD, PhD         
Sponsors and Collaborators
Taejoon Pharmaceutical Co., Ltd.

Responsible Party: Taejoon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03419975     History of Changes
Other Study ID Numbers: TJO-002-301
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents