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

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03067415
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 16.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Primary Open Angle; Ocular Hypertension	Drug: D565H(Latanoprost 25㎍/㎖); Drug: D565(Latanoprost 50㎍/㎖)	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: AssignmentAssignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Mar 30, 2017
• Anticipated Primary Completion Date: Sep 10, 2017
• Anticipated Study Completion Date: Sep 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: D565H(Latanoprost 25㎍/㎖) 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㎍/㎖) 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. Changes in intraocular pressure by measurement time [2 weeks, 4 weeks]

   IOP variation by measurement time

Other Outcome Measures

1. Safety assessed by the incidence of adverse event, History, Medication [up to 4 weeks]

   Adverse events, history, medications, signs of vitality, physical examination, etc.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

1. Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation -25dB or more)

2. Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)

3. Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months

4. 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

1. Subjects who wore need to wear contact lenses during the study

2. 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

3. Subjects with known hypersensitivity to investigational product

4. Women who are nursing, pregnant or planning pregnancy during the study

5. Subjects with bronchial asthma or history

6. Subjects who have received any other investigational product within 1 month prior to the first dosing

7. Impossible subjects who participate in clinical trial by investigator's decision

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hosipital	Seoul	Jongno	Korea, Republic of

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Principal Investigator: KiHo Park, Seoul National University Hosipital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT03067415
• Other Study ID Numbers: 171GLC16020
• First Posted: Mar 1, 2017
• Last Update Posted: Jul 21, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chong Kun Dang Pharmaceutical: Glaucoma, Primary Open Angle; Ocular hypertension; CKD-351
• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension; Latanoprost

Study Results

No Results Posted as of Jul 21, 2017