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

Multi Center, Randomized, Double-blind, Active Controlled, Parallel Design, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-351 in Primary Open Angle Glaucoma or Ocular Hypertension Patients

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

Study Overview

• Status: Unknown
• Conditions: Ocular Hypertension; Primary Open-angle Glaucoma
• Intervention / Treatment: Drug: CKD-351; Drug: D930; Drug: Latanoprost; Drug: Placebo of CKD-351; Drug: Placebo of CKD-351; Drug: Placebo of D930

Detailed Description

Multi center, Randomized, Double-blind, Active controlled, Parallel design, Phase 3 trial to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients.

• Study Type: Interventional
• Enrollment (Anticipated): 384
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno
    • Seoul, Jongno, Korea, Republic of
      • Seoul National University Hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at more than one eye
2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2

3. Subjects who were diagnosed as below with monocular or both eye

   • Acute or Chronic Closed-Angle Glaucoma
   • Secondary Glaucoma
   • Pseudoexfoliation Glaucoma
   • Neovascular Glaucoma
   • Aphakia
   • Phacocyst capsular torn intraocular lens
4. Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB)
5. Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)
6. Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months

7. Subjects who have medical history following

   • Subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery
   • Subjects who received topical or systemic steroids within the last 1 months
8. Subjects who wore need to wear contact lenses during the study
9. Women who are nursing, pregnant or planning pregnancy during the study
10. Subjects with bronchial asthma or history
11. Subjects with severe renal impairment (creatinine clearance <30 ml / min at screening) or hyperchloremic acidosis
12. Subjects who have received any other investigational product within 1 month prior to randomization
13. Impossible subjects who participate in clinical trial by investigator's decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Latanoprost	Drug: Latanoprost; once a day; Drug: Placebo of CKD-351; once a day; Drug: Placebo of CKD-351; twice a day; Drug: Placebo of D930; three times a day
Experimental: CKD-351; Latanoprost+D930	Drug: CKD-351; twice a day; Other Names: Latanoprost+D930; Drug: D930; three times a day
Active Comparator: D930	Drug: D930; three times a day; Drug: Placebo of CKD-351; once a day; Drug: Placebo of CKD-351; twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in mean intraocular pressure at 12 weeks compared to baseline	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline		Baseline, 4 weeks, 8 weeks
Changes in intraocular pressure by measurement time	IOP variation by measurement time	4 weeks, 8 weeks, 12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Safety assessed by number of participants with treatment-related adverse events	up to 24 weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: KiHo Park, Seoul National University Hosipital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 7, 2018
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Ocular Hypertension; Primary Open-angle Glaucoma; CKD-351
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: 171GLC18006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No