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

Phase 3

• Conditions: Primary Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Latanoprost; Drug: CKD-351; Drug: D930; Drug: Placebo of CKD-351; Drug: Placebo of D930

• Registration Number: NCT03762369
• 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, 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 Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-30
• Last Update Submitted: 2018-11-30
• Study First Posted: 2018-12-03
• Last Update Posted: 2018-12-03
• Study Start: 2018-12-07
• Primary Completion: 2022-02-28
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 384

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKD-351	D930	Latanoprost+D930
Latanoprost	Latanoprost	-
Latanoprost	Placebo of D930	-
D930	Placebo of CKD-351	-
Latanoprost	Placebo of CKD-351	-
D930	D930	-
CKD-351	CKD-351	Latanoprost+D930

Primary Outcome Measures

Name	Time	Method
Change in mean intraocular pressure at 12 weeks compared to baseline	Baseline, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline	Baseline, 4 weeks, 8 weeks
Changes in intraocular pressure by measurement time	4 weeks, 8 weeks, 12 weeks	IOP variation by measurement time

Trial Locations

Locations (1)

Seoul National University Hosipital; 🇰🇷 Seoul, Jongno, Korea, Republic of