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

NCT ID: NCT06078592

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-08
• Study Completion Date: 2022-12-23

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

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

Conditions

Glaucoma; Ocular Hypertensive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BRIDIN-plus Eye drops

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

Group Type: EXPERIMENTAL

BRIDIN-plus Eye drops

Intervention Type: DRUG

BRIDIN-plus Eye drops

Combigan Eye drops

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

Group Type: ACTIVE_COMPARATOR

Combigan Eye drops

Intervention Type: DRUG

Combigan Eye drops

Interventions

BRIDIN-plus Eye drops

BRIDIN-plus Eye drops

Intervention Type: DRUG

Combigan Eye drops

Combigan Eye drops

Intervention Type: DRUG

Other Intervention Names

Brimonidine tartrate 2.0mg, Timolol maleate 6.8mg(without preservative); Brimonidine tartrate 2.0mg, Timolol maleate 6.8mg(with preservative)

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

CHA University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seungsoo Rho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHA Bundang Medical Center

Locations

Seungsoo Rho

Seoul, Seongnam, Bundang-gu, South Korea

Countries

South Korea

Other Identifiers

BCT

Identifier Type: -

Identifier Source: org_study_id