Ocular Hypertension, Primary Open-angle Glaucoma
Conditions
Keywords
Primary Open-angle Glaucoma, Ocular Hypertension, CKD-351
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.
Interventions
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean intraocular pressure at 12 weeks compared to baseline | Baseline, 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame |
|---|---|
| Safety assessed by number of participants with treatment-related adverse events | up to 24 weeks |
Countries
South Korea
Contacts
Primary ContactKiHo Park
Outcome results
None listed