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

NCT06078592 | Completed Phase 4

• 1 other identifier: BCT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Glaucoma; Ocular Hypertensive

Outcome Measures

Primary Outcomes (4)

• Corneal staining test

  Corneal staining score is evaluated according to the oxford grading system after blue fluorescein staining under a slit lamp biomicroscope of cobalt blue light source using a yellow filter. Corneal surface is divided into 3 areas and evaluated from grade 0 indicating that there is no staining to grade 5 indicating denser staining due to severe corneal defect. (The score ranges from 0 to 5, with higher scores indicate worse symtoms.)

  12 weeks after administration

• Conjunctival staining test

  Conjunctival staining score is evaluated after blue fluorescein staining under a slit lamp biomicroscope, by NEI(The National Eye Institute) scale. Conjunctival surface is divided into 6 areas and evaluated from grade 0 indicating that there is no staining to grade 3 indicating denser staining due to severe conjunctival defect.

  12 weeks after administration

• Ocular surface disease index (OSDI)

  Ocular surface disease index include 12 items comprising of assessment of vision related functioning (5 items), ocular symptoms(4 items) and environmental factors that may cause symptoms (3 items). Each item is 5-point Likert scale in which a higher score indicates more severe symptoms. A total score is classified as normal (0-12), mild (13-22), moderate (23-32) and severe (33 or more) and it is evaluated based on grades and score changes

  12 weeks after administration

• Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance)

  treatment administration satisfaction and ocular tolerance are evaluated through questionnaires. Treatment administration satisfaction questionnaire includes the convenience of use and storage of investigational products and ocular tolerance evaluation questionnaire includes symptom severity(0\~3) and symptom duration(briefly, persistent) for 8 symptoms of stinging/burning, sticky eyes, itching, blurred vision, foreign-body sensation, dryness, photophobia, pain. Medication compliance is evaluated with MGL-MAQ-Korean version.

  12 weeks after administration

Secondary Outcomes (6)

• Corneal staining test

  4 weeks after administration

• Conjunctival staining test

  4 weeks after administration

• Ocular surface disease index (OSDI)

  4 weeks after administration

• IOP(Intraocular pressure)

  4, 12 weeks after administration

• Tear break up time (TBUT)

  4, 12 weeks after administration

Study Arms (2)

BRIDIN-plus Eye drops

EXPERIMENTAL

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

Drug: BRIDIN-plus Eye drops

Combigan Eye drops

ACTIVE COMPARATOR

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

Drug: Combigan Eye drops

Interventions

BRIDIN-plus Eye drops DRUG

BRIDIN-plus Eye drops

Also known as: Brimonidine tartrate 2.0mg, Timolol maleate 6.8mg(without preservative)

BRIDIN-plus Eye drops

Combigan Eye drops DRUG

Combigan Eye drops

Also known as: Brimonidine tartrate 2.0mg, Timolol maleate 6.8mg(with preservative)

Combigan Eye drops

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHA University: lead
• Hanlim Pharm. Co., Ltd.: collaborator

Study Sites (1)

Seungsoo Rho

Seoul, Seongnam, Bundang-gu, 13497, South Korea

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Brimonidine Tartrate; Timolol; Preservatives, Pharmaceutical

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Morpholines; Oxazines; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Seungsoo Rho, MD, PhD

  CHA Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: October 12, 2023
• Study Start: October 8, 2021
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

KR (1)