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.
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
