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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04448223

Enrollment

100

Registered

2020-06-25

Start date

2020-06-11

Completion date

2022-12-05

Last updated

2020-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Primary Open Angle Glaucoma

Keywords

Primary Open-angle Glaucoma, Ocular Hypertension, CKD-351

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

Interventions

DRUGCKD-351

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

DRUGLatanoprost+Dorzolmamide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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 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.

Design outcomes

Primary

Measure	Time frame	Description
Change in mean intraocular pressure for efficacy measurement	Baseline, 4 weeks	Change in mean intraocular pressure at 4 weeks compared to baseline

Secondary

Measure	Time frame	Description
Change in mean intraocular pressure for efficacy measurement	Baseline, 2 weeks	Change in mean intraocular pressure at 2 weeks compared to baseline
Changes in intraocular pressure for efficacy measurement	Baseline, 2 weeks, 4 weeks	Intraocular pressure by each measurement time

Countries

South Korea

Contacts

Primary ContactKiHo Park

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026