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

• Sponsor: Taejoon Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03419975
• Collaborator: (none)
• Enrollment: 146
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.2
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Apr 26, 2016
• Actual Primary Completion Date: Dec 28, 2017
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in diurnal IOP at Week 12 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chan Yun, Kim	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: NCT03419975
• Other Study ID Numbers: TJO-002-301
• First Posted: Feb 5, 2018
• Last Update Posted: Sep 4, 2019
• Last Verified: Jan 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Latanoprost

Study Results

No Results Posted as of Sep 4, 2019