Glaucoma, Primary Open Angle, Ocular Hypertension
Conditions
Keywords
Glaucoma, Primary Open Angle, Ocular hypertension, CKD-351
Brief summary
Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily.
Detailed description
A Multi center, Randomized, Double-blind, Parallel design, Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily in primary open angle glaucoma or ocular hypertension patients.
Interventions
DRUGD565H(Latanoprost 25㎍/㎖)
D565H twice daily
DRUGD565(Latanoprost 50㎍/㎖)
D565 once daily
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Assignment
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) measured at Visit 1 and Visit 2(AM 09:00) above 35 mmHg at more than one eye 2. Subjects with a maximum corrected visual acuity of less or than 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 or more) 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 * Glaucoma surgery * 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 6 months 8. Subjects who wore need to wear contact lenses during the study 9. Subjects who have drug interaction with the investigational product, have a significant effect on the intraocular pressure, or who may have an effect on the clinical trial results 10. Subjects with known hypersensitivity to investigational product 11. Women who are nursing, pregnant or planning pregnancy during the study 12. Subjects with bronchial asthma or history 13. Subjects who have received any other investigational product within 1 month prior to the first dosing 14. Impossible subjects who participate in clinical trial by investigator's decision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean intraocular pressure at 4 weeks compared to baseline | Baseline, 4 weeks | Mean baseline intraocular pressure change Mean intraocular pressure change after 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean intraocular pressure at 2 weeks compared to baseline | Baseline, 2 weeks | Mean baseline intraocular pressure change Mean intraocular pressure change after 2 weeks |
| Changes in intraocular pressure by measurement time | 2 weeks, 4 weeks | IOP variation by measurement time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by the incidence of adverse event, History, Medication | up to 4 weeks | Adverse events, history, medications, signs of vitality, physical examination, etc. |
Countries
South Korea
Contacts
Primary ContactKiHo Park
Outcome results
None listed