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A Clinical Study to Evaluate the Efficacy and Safety of CKD-351 | Clinical Trials | Clareo Health

UNKNOWNPHASE3

A Clinical Study to Evaluate the Efficacy and Safety of CKD-351

Multi Center, Randomized, Double-blind, Active Controlled, Parallel Design, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-351 in Primary Open Angle Glaucoma or Ocular Hypertension Patients

NCT03762369•Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate efficacy and safety of CKD-351.

Detailed Description

Multi center, Randomized, Double-blind, Active controlled, Parallel design, Phase 3 trial to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. More than the age of 19 years old
•2. Subjects who has primary Open-Angle Glaucoma or Ocular Hypertension
•3. Subjects who sign on an informed consent form willingly

Exclusion Criteria

•1. Subjects with IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at more than one eye
•2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2
•3. Subjects who were diagnosed as below with monocular or both eye
•* Acute or Chronic Closed-Angle Glaucoma
•* Secondary Glaucoma
•* Pseudoexfoliation Glaucoma
•* Neovascular Glaucoma
•* Aphakia
•* Phacocyst capsular torn intraocular lens
•4. Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB)
+11 more criteria

Locations (1)

Seoul National University Hosipital

Seoul, Jongno, South Korea

Key Dates

Start Date

December 7, 2018

Primary Completion Date

February 28, 2022

Completion Date

May 30, 2022

Last Updated

December 3, 2018

Enrollment

384

ESTIMATED participants

Conditions

Primary Open-angle GlaucomaOcular Hypertension

Interventions

CKD-351

DRUG

Latanoprost

DRUG

D930

DRUG

Placebo of CKD-351

DRUG

Placebo of CKD-351

DRUG

Placebo of D930

DRUG

Contacts

KiHo Park

CONTACT

82-10-3458-3172 kihopark@snu.ac.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study to Evaluate the Efficacy and Safety of CKD-351

Inclusion Criteria

Exclusion Criteria

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