Overview

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

Status:
Active, not recruiting
Trial end date:
2021-01-29
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CHA University
Collaborator:
Hanlim Pharm. Co., Ltd.
Treatments:
Brimonidine Tartrate
Ophthalmic Solutions
Criteria
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