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

Ocular Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03067415
• Other study ID #: 171GLC16020
• Status: Recruiting
• Phase: Phase 2
• First received: February 24, 2017
• Last updated: July 18, 2017
• Start date: March 30, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: February 2017
• Source: Chong Kun Dang Pharmaceutical
• Contact: KiHo Park
• Phone: 82-10-3458-3172
• Email: kihopark[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: September 30, 2017
• Est. primary completion date: September 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• D565H(Latanoprost 25?/?)
D565H twice daily
• D565(Latanoprost 50?/?)
D565 once daily

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hosipital	Seoul	Jongno

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety assessed by the incidence of adverse event, History, Medication	Adverse events, history, medications, signs of vitality, physical examination, etc.	up to 4 weeks
Primary	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	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
Secondary	Changes in intraocular pressure by measurement time	IOP variation by measurement time	2 weeks, 4 weeks