Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT04448223
NCT04448223UnknownPhase 2

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

Chong Kun Dang Pharmaceutical1 site in 1 country100 target enrollmentStarted: June 11, 2020Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Enrollment
100
Locations
1
Primary Endpoint
Change in mean intraocular pressure for efficacy measurement
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •More than the age of 19 years old
  • •Subjects who has primary open-angle glaucoma or ocular hypertension
  • •Subjects who sign on an informed consent form willingly

Exclusion Criteria

  • •Subjects with intraocular pressure ≥ 35 mmHg at Visit 1 or Visit 2 (AM 09:00)
  • •Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 1 or Visit 2
  • •Subjects who were diagnosed as below
  • •Intraocular lens
  • •Acute or Chronic Closed-Angle Glaucoma
  • •Secondary Glaucoma
  • •Subjects with ocular inflammation or infection within the last 3 months
  • •Subjects with significant history of ocular trauma during the last 6 months or who underwent surgical opthalmic surgery
  • •Subjects who received topical or systemic steroids within the last 1 month.

Arms & Interventions

CKD-351

Experimental

CKD-351

Intervention: CKD-351 (Drug)

Latanoprost+Dorzolamide

Active Comparator

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

Intervention: Latanoprost+Dorzolmamide (Drug)

Outcomes

Primary Outcomes

Change in mean intraocular pressure for efficacy measurement

Time Frame: Baseline, 4 weeks

Change in mean intraocular pressure at 4 weeks compared to baseline

Secondary Outcomes

  • Change in mean intraocular pressure for efficacy measurement(Baseline, 2 weeks)
  • Changes in intraocular pressure for efficacy measurement(Baseline, 2 weeks, 4 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Phase 3
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351Ocular HypertensionPrimary Open-angle Glaucoma
NCT03762369Chong Kun Dang Pharmaceutical384
Completed
Phase 3
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-495Gastritis
NCT04255589Chong Kun Dang Pharmaceutical242
Completed
Phase 3
Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 TabletHypertensive Patients With Dyslipidemia
NCT03583905Chong Kun Dang Pharmaceutical154
Completed
Phase 1
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355Alzheimer's Disease (AD)
NCT03802162Chong Kun Dang Pharmaceutical60
Completed
Phase 3
Clinical Trial to Evaluate the Efficacy and Safety of CKD-386Dyslipidemia Patients With Hypertension
NCT04312698Chong Kun Dang Pharmaceutical100
A Clinical Study to Evaluate the Efficacy... | Clinical Trial