search
Back to results

Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily

Primary Purpose

Glaucoma, Primary Open Angle, Ocular Hypertension

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
D565H(Latanoprost 25㎍/㎖)
D565(Latanoprost 50㎍/㎖)
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Primary Open Angle focused on measuring Glaucoma, Primary Open Angle, Ocular hypertension, CKD-351

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HosipitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

D565H(Latanoprost 25㎍/㎖)

D565(Latanoprost 50㎍/㎖)

Arm Description

D565H(Latanoprost 25㎍/㎖)

D565(Latanoprost 50㎍/㎖)

Outcomes

Primary Outcome Measures

Change in mean intraocular pressure at 4 weeks compared to baseline
Mean baseline intraocular pressure change Mean intraocular pressure change after 4 weeks

Secondary Outcome Measures

Change in mean intraocular pressure at 2 weeks compared to baseline
Mean baseline intraocular pressure change Mean intraocular pressure change after 2 weeks
Changes in intraocular pressure by measurement time
IOP variation by measurement time

Full Information

First Posted
February 24, 2017
Last Updated
July 18, 2017
Sponsor
Chong Kun Dang Pharmaceutical
search

1. Study Identification

Unique Protocol Identification Number
NCT03067415
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
September 10, 2017 (Anticipated)
Study Completion Date
September 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Primary Open Angle, Ocular Hypertension
Keywords
Glaucoma, Primary Open Angle, Ocular hypertension, CKD-351

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D565H(Latanoprost 25㎍/㎖)
Arm Type
Experimental
Arm Description
D565H(Latanoprost 25㎍/㎖)
Arm Title
D565(Latanoprost 50㎍/㎖)
Arm Type
Active Comparator
Arm Description
D565(Latanoprost 50㎍/㎖)
Intervention Type
Drug
Intervention Name(s)
D565H(Latanoprost 25㎍/㎖)
Other Intervention Name(s)
Arm A
Intervention Description
D565H twice daily
Intervention Type
Drug
Intervention Name(s)
D565(Latanoprost 50㎍/㎖)
Other Intervention Name(s)
Arm B
Intervention Description
D565 once daily
Primary Outcome Measure Information:
Title
Change in mean intraocular pressure at 4 weeks compared to baseline
Description
Mean baseline intraocular pressure change Mean intraocular pressure change after 4 weeks
Time Frame
Baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Change in mean intraocular pressure at 2 weeks compared to baseline
Description
Mean baseline intraocular pressure change Mean intraocular pressure change after 2 weeks
Time Frame
Baseline, 2 weeks
Title
Changes in intraocular pressure by measurement time
Description
IOP variation by measurement time
Time Frame
2 weeks, 4 weeks
Other Pre-specified Outcome Measures:
Title
Safety assessed by the incidence of adverse event, History, Medication
Description
Adverse events, history, medications, signs of vitality, physical examination, etc.
Time Frame
up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: More than the age of 19 years old Subjects who has primary Open-Angle Glaucoma or Ocular Hypertension Subjects who sign on an informed consent form willingly Exclusion Criteria: Subjects with IOP(Intraocular Pressure) measured at Visit 1 and Visit 2(AM 09:00) above 35 mmHg at more than one eye Subjects with a maximum corrected visual acuity of less or than 0.3 in the selected evaluation eye at visit 2 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 Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation -25dB or more) Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema) Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months 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 Subjects who wore need to wear contact lenses during the study 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 Subjects with known hypersensitivity to investigational product Women who are nursing, pregnant or planning pregnancy during the study Subjects with bronchial asthma or history Subjects who have received any other investigational product within 1 month prior to the first dosing Impossible subjects who participate in clinical trial by investigator's decision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KiHo Park
Phone
82-10-3458-3172
Email
kihopark@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KiHo Park
Organizational Affiliation
Seoul National University Hosipital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hosipital
City
Seoul
State/Province
Jongno
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KiHo Park, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily

We'll reach out to this number within 24 hrs