Clinical trial NCT03067415: Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glaucoma, Primary Open Angle
Ocular Hypertension
Keywords: Glaucoma, Primary Open Angle
Ocular hypertension
CKD-351
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 98
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: TREATMENT

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.

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) 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

Primary outcomes:
measure: Change in mean intraocular pressure at 4 weeks compared to baseline
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change in mean intraocular pressure at 2 weeks compared to baseline
timeFrame: Baseline, 2 weeks
measure: Changes in intraocular pressure by measurement time
timeFrame: 2 weeks, 4 weeks
Other outcomes:
measure: Safety assessed by the incidence of adverse event, History, Medication
timeFrame: up to 4 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: