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

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.

Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily.

Study Overview

• Status: Unknown
• Conditions: Ocular Hypertension; Glaucoma, Primary Open Angle
• Intervention / Treatment: Drug: D565H(Latanoprost 25㎍/㎖); Drug: D565(Latanoprost 50㎍/㎖)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: KiHo Park; Phone Number: 82-10-3458-3172; Email: kihopark@snu.ac.kr

Study Locations

• Korea, Republic of
  • Jongno
    • Seoul, Jongno, Korea, Republic of
      • Recruiting
      • Seoul National University Hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D565H(Latanoprost 25㎍/㎖)	Drug: D565H(Latanoprost 25㎍/㎖); D565H twice daily; Other Names: Arm A; Drug: D565(Latanoprost 50㎍/㎖); D565 once daily; Other Names: Arm B
Active Comparator: D565(Latanoprost 50㎍/㎖)	Drug: D565H(Latanoprost 25㎍/㎖); D565H twice daily; Other Names: Arm A; Drug: D565(Latanoprost 50㎍/㎖); D565 once daily; Other Names: Arm B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean intraocular pressure at 4 weeks compared to baseline	Mean baseline intraocular pressure change Mean intraocular pressure change after 4 weeks	Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean intraocular pressure at 2 weeks compared to baseline	Mean baseline intraocular pressure change Mean intraocular pressure change after 2 weeks	Baseline, 2 weeks
Changes in intraocular pressure by measurement time	IOP variation by measurement time	2 weeks, 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by the incidence of adverse event, History, Medication	Adverse events, history, medications, signs of vitality, physical examination, etc.	up to 4 weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: KiHo Park, Seoul National University Hosipital

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Anticipated): September 10, 2017
• Study Completion (Anticipated): September 30, 2017

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Ocular hypertension; CKD-351; Glaucoma, Primary Open Angle
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: 171GLC16020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No