Clinical trial NCT03762369: A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Open-angle Glaucoma
Ocular Hypertension
Keywords: Primary Open-angle Glaucoma
Ocular Hypertension
CKD-351
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 384
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in mean intraocular pressure at 12 weeks compared to baseline
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Changes in intraocular pressure by measurement time
timeFrame: 4 weeks, 8 weeks, 12 weeks
Other outcomes:
measure: Safety assessed by number of participants with treatment-related adverse events
timeFrame: up to 24 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hosipital
state: Jongno
Study officials:
affiliation: Seoul National University Hosipital
name: KiHo Park
role: PRINCIPAL_INVESTIGATOR
References: