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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04448223
• Other study ID #: A71_04GLC1915
• Status: Recruiting
• Phase: Phase 2
• Start date: June 11, 2020
• Est. completion date: December 5, 2022

Study information

• Verified date: June 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: KiHo Park
• Phone: +82-10-3458-3172
• Email: kihopark[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Drug:
• CKD-351
Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day
• Latanoprost+Dorzolmamide
Latanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes a day

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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