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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2017-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Glaucoma, Primary Open Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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D565H(Latanoprost 25㎍/㎖)

Group Type EXPERIMENTAL

D565H(Latanoprost 25㎍/㎖)

Intervention Type DRUG

D565H twice daily

D565(Latanoprost 50㎍/㎖)

Intervention Type DRUG

D565 once daily

D565(Latanoprost 50㎍/㎖)

Group Type ACTIVE_COMPARATOR

D565H(Latanoprost 25㎍/㎖)

Intervention Type DRUG

D565H twice daily

D565(Latanoprost 50㎍/㎖)

Intervention Type DRUG

D565 once daily

Interventions

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D565H(Latanoprost 25㎍/㎖)

D565H twice daily

Intervention Type DRUG

D565(Latanoprost 50㎍/㎖)

D565 once daily

Intervention Type DRUG

Other Intervention Names

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Arm A Arm B

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No