Comparison of Efficacy and Ocular Surface Assessment Between BRIDIN-plus and Combigan in Glaucoma or Ocular Hypertensive (BCT)

CHA University

Status and phase: Completed; Phase 4

Conditions: Ocular Hypertensive; Glaucoma

Treatments: Drug: Combigan Eye drops; Drug: BRIDIN-plus Eye drops

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06078592

BCT

Details and patient eligibility

About

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, Investigator-blind, Active-control, Randomized, Multi-center Trial

Full 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-use formula COMBIGAN® eye drops after 12 weeks of administration to glaucoma or ocular hypertensive patients.

Enrollment: 60 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Male or female adults who are 19 years or older with a diagnosis of glaucoma or intraocular hypertension
2. A person who has completed an appropriate washout period if glaucoma treatment medication has been used
3. Intraocular pressure measured by Goldman applanation tonometer at visit 2 is 15mmHg or above and less than 40mmHg
4. A person who has signed the written consent form by himself/herself or by a legal representative

Exclusion Criteria:

1. A patient with primary close angle glaucoma, congenital glaucoma, secondary glaucoma caused by steroids
2. Best corrected visual acuity of both eyes measured by Snellen acuity charts is 20/80 (decimal 0.25) or less
3. A patient with progressive intraocular inflammation
4. Central corneal thickness is less than 470um or greater than 591ums
5. A patient who has had lacrimal punctual occlusion done within the last 3 monthds or who has eye surgery plan during the clinical study
6. Pregnant or lactating women
7. Other cases if investigators judge the patient is difficult to participate the clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

BRIDIN-plus Eye drops

Experimental group

Description:

One drop in the eyes, twice a day, approximately 12 hours apart.

Treatment:

Drug: BRIDIN-plus Eye drops

Combigan Eye drops

Active Comparator group

Description:

One drop in the eyes, twice a day, approximately 12 hours apart.

Treatment:

Drug: Combigan Eye drops