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

CHA University

Status and phase: Unknown; Phase 4

Conditions: Ocular Hypertensive; Glaucoma

Treatments: Drug: Brimonidine Tartrate 1.5mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04647461

BAT

Details and patient eligibility

About

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

Full description

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)

Enrollment: 61 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups

BRIDIN-T Eye drops 0.15%(Non preservative)

Experimental group

Description:

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

Treatment:

Drug: Brimonidine Tartrate 1.5mg

Drug: Brimonidine Tartrate 1.5mg

ALPHAGAN-P Eye drops 0.15%(Preservatives)

Active Comparator group

Description:

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

Treatment:

Drug: Brimonidine Tartrate 1.5mg

Drug: Brimonidine Tartrate 1.5mg