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Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial

NCT ID: NCT04647461

Last Updated: 2020-12-01

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

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2021-01-29

Brief Summary

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Comparison of Efficacy and Ocular Surface Disease Assessment between BRIDIN-T Eye drops 0.15% and ALPHAGAN-P Eye drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial

Detailed Description

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Following 12 weeks of administration of BRIDIN-T Eye drops 0.15%(non preservative) or ALPHAGAN-P Eye drops 0.15%(preservatives) for patients with glaucoma or Ocular Hypertensive Patients. The use of BRIDIN-T Eye drops(non preservative) is less harmful to external ophthalmicus diseases and increase of medication compliance for ophthalmic drugs than the ALPHAGAN-P Eye drops 0.15%(preservatives)

Conditions

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Glaucoma Ocular Hypertensive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BRIDIN-T Eye drops 0.15%(Non preservative)

Brimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes

Group Type EXPERIMENTAL

Brimonidine Tartrate 1.5mg

Intervention Type DRUG

1 drop 3 times a day for 12 weeks to target eyes

ALPHAGAN-P Eye drops 0.15%(Preservatives)

Brimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes

Group Type ACTIVE_COMPARATOR

Brimonidine Tartrate 1.5mg

Intervention Type DRUG

1 drop 3 times a day for 12 weeks to target eyes

Interventions

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Brimonidine Tartrate 1.5mg

1 drop 3 times a day for 12 weeks to target eyes

Intervention Type DRUG

Brimonidine Tartrate 1.5mg

1 drop 3 times a day for 12 weeks to target eyes

Intervention Type DRUG

Other Intervention Names

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BRIDIN-T Eye drops 0.15% ALPHAGAN-P Eye drops 0.15%

Eligibility Criteria

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Inclusion Criteria

1. Adult(Male or Female) over 19 years who were diagnosed with glaucoma or ocular hypertension
2. In the case of a person receiving a glaucoma treatment drug, a person who has completed the appropriate in wash-out period for the existing glaucoma drug before the investigational product is administered.
3. Intraocular pressure (IOP) \>/= 15mmHg and \< 40mmHg in each eye using Goldmann applanation tonometry at visit 2
4. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria

1. Patients with primary closed-angle glaucoma, congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
2. BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
3. Those who have ongoing medical history as intraocular inflamation.
4. Central corneal thickness is not between 470um and 591um.
5. Patients who have received lacrimal passive occlusion within the last three months or who have surgery plans during the clinical trial period.
6. Pregnant or nursing women.
7. Patients judged coexisting disease that could interfere with the completion of the treatment or safety of this clinical trial. Patients that other researchers are determined inadequately
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role collaborator

CHA University

OTHER

Sponsor Role lead

Responsible Party

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Seungsoo Rho

Associate Professor., M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHA University Bundang Medical Center

Seongnam, Bundang-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BAT

Identifier Type: -

Identifier Source: org_study_id