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

Phase 2

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: CKD-351; Drug: Latanoprost+Dorzolmamide

• Registration Number: NCT04448223
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Study Timeline

• Study First Submitted: 2020-05-11
• Status Verified: 2020-06
• Study Start: 2020-06-11
• Study First Submitted QC: 2020-06-24
• Last Update Submitted: 2020-06-24
• Study First Posted: 2020-06-25
• Last Update Posted: 2020-06-25
• Primary Completion: 2022-12-05
• Study Completion: 2022-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKD-351	CKD-351	CKD-351
Latanoprost+Dorzolamide	Latanoprost+Dorzolmamide	Latanoprost(50ul/ml) Dorzolmamide(20mg/ml)

Primary Outcome Measures

Name	Time	Method
Change in mean intraocular pressure for efficacy measurement	Baseline, 4 weeks	Change in mean intraocular pressure at 4 weeks compared to baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of