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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03762369
• Other study ID #: 171GLC18006
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 7, 2018
• Est. completion date: May 30, 2022

Study information

• Verified date: November 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: KiHo Park
• Phone: 82-10-3458-3172
• Email: kihopark[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 384
• Est. completion date: May 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-angle Glaucoma

Intervention

Drug:
• CKD-351
twice a day
• Latanoprost
once a day
• D930
three times a day
• Placebo of CKD-351
once a day
• Placebo of CKD-351
twice a day
• Placebo of D930
three times a day

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hosipital	Seoul	Jongno

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety assessed by number of participants with treatment-related adverse events		up to 24 weeks
Primary	Change in mean intraocular pressure at 12 weeks compared to baseline		Baseline, 12 weeks
Secondary	Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline		Baseline, 4 weeks, 8 weeks
Secondary	Changes in intraocular pressure by measurement time	IOP variation by measurement time	4 weeks, 8 weeks, 12 weeks