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

NCT ID: NCT04448223

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-11
• Study Completion Date: 2022-12-05

Brief Summary

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

Detailed Description

Multi center, Randomized, Open-label, Active controlled, Phase 2 trial, Proof Of Concept Study to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CKD-351

CKD-351

Group Type: EXPERIMENTAL

CKD-351

Intervention Type: DRUG

Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day

Latanoprost+Dorzolamide

Latanoprost(50ul/ml) Dorzolmamide(20mg/ml)

Group Type: ACTIVE_COMPARATOR

Latanoprost+Dorzolmamide

Intervention Type: DRUG

Latanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes a day

Interventions

CKD-351

Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day

Intervention Type: DRUG

Latanoprost+Dorzolmamide

Latanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes a day

Intervention Type: DRUG

Eligibility Criteria

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 intraocular pressure ≥ 35 mmHg at Visit 1 or Visit 2 (AM 09:00)

2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 1 or Visit 2

3. Subjects who were diagnosed as below

• Aphakia
• Intraocular lens
• Acute or Chronic Closed-Angle Glaucoma
• Secondary Glaucoma

4. Subjects with ocular inflammation or infection within the last 3 months

5. Subjects with significant history of ocular trauma during the last 6 months or who underwent surgical opthalmic surgery

6. Subjects who received topical or systemic steroids within the last 1 month.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

KiHo Park, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

KiHo Park

Role: CONTACT

kihopark@snu.ac.kr

+82-10-3458-3172

Facility Contacts

KiHo Park, MD

Role: primary

Other Identifiers

A71_04GLC1915

Identifier Type: -

Identifier Source: org_study_id