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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03762369
Other study ID # 171GLC18006
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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