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

Chong Kun Dang

Status and phase: Unknown; Phase 2

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Treatments: Drug: CKD-351; Drug: Latanoprost+Dorzolmamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04448223

A71_04GLC1915

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CKD-351

Experimental group

Description:

CKD-351

Treatment:

Drug: CKD-351

Latanoprost+Dorzolamide

Active Comparator group

Description:

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

Treatment:

Drug: Latanoprost+Dorzolmamide