Status:
COMPLETED
Comparison of Efficacy and Ocular Surface Assessment Between BRIDIN-plus and Combigan in Glaucoma or Ocular Hypertensive
Lead Sponsor:
CHA University
Collaborating Sponsors:
Hanlim Pharm. Co., Ltd.
Conditions:
Glaucoma
Ocular Hypertensive
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
Comparison of Efficacy and Ocular Surface Disease Assessment between BRIDIN-plus Eye drops and Combigan Eye drops in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investig...
Detailed Description
The purpose of this clinical trial is to prove lower negative effects on ocular surface disease and higher patient compliance of a single-use formula BRIDIN-PLUS® eye drops group, comparing to a multi...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female adults who are 19 years or older with a diagnosis of glaucoma or intraocular hypertension
- A person who has completed an appropriate washout period if glaucoma treatment medication has been used
- Intraocular pressure measured by Goldman applanation tonometer at visit 2 is 15mmHg or above and less than 40mmHg
- A person who has signed the written consent form by himself/herself or by a legal representative
- Exclusion Criteria:
- A patient with primary close angle glaucoma, congenital glaucoma, secondary glaucoma caused by steroids
- Best corrected visual acuity of both eyes measured by Snellen acuity charts is 20/80 (decimal 0.25) or less
- A patient with progressive intraocular inflammation
- Central corneal thickness is less than 470um or greater than 591ums
- A patient who has had lacrimal punctual occlusion done within the last 3 monthds or who has eye surgery plan during the clinical study
- Pregnant or lactating women
- Other cases if investigators judge the patient is difficult to participate the clinical trial
Exclusion
Key Trial Info
Start Date :
October 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06078592
Start Date
October 8 2021
End Date
December 23 2022
Last Update
March 26 2025
Active Locations (1)
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1
Seungsoo Rho
Seoul, Seongnam, Bundang-gu, South Korea, 13497