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

Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN- PLUS® Eye Drops and COMBIGAN® Eye Drops in Glaucoma or Ocular Hypertensive Patients

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

Study Overview

• Status: Completed
• Conditions: Glaucoma; Ocular Hypertensive
• Intervention / Treatment: Drug: BRIDIN-plus Eye drops; Drug: Combigan Eye drops

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Bundang-gu
    • Seoul, Seongnam, Bundang-gu, Korea, Republic of, 13497
      • Seungsoo Rho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BRIDIN-plus Eye drops; One drop in the eyes, twice a day, approximately 12 hours apart.	Drug: BRIDIN-plus Eye drops; One drop in the eyes, twice a day, approximately 12 hours apart.; Other Names: Brimonidine tartrate 2.0mg, Timolol maleate 6.8mg(without preservative)
Active Comparator: Combigan Eye drops; One drop in the eyes, twice a day, approximately 12 hours apart.	Drug: Combigan Eye drops; One drop in the eyes, twice a day, approximately 12 hours apart.; Other Names: Brimonidine tartrate 2.0mg, Timolol maleate 6.8mg(with preservative)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	4 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.	4 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	4 weeks after administration
IOP(Intraocular pressure)	The same tonometer (Goldman applanation tonometer) should be used. In the case of bilateral glaucoma, intraocular pressure of the right eye is first measured and a higher one is used. If intraocular pressures of both eyes are the same, intraocular pressures of the right eye is used. In unilateral glaucoma, intraocular pressures of an eye with glaucoma is used.	4, 12 weeks after administration
Tear break up time (TBUT)	Corneal staining score is evaluated after blue fluorescein staining on a 6-point scale according to oxford grading system under a slit lamp biomicroscope with a yellow filter offering cobalt blue light. After blue fluorescein staining, a participant is asked to blink their eyes. Then, time from the last blinking to the point when black spots, lines or loss of fluorescein are observed is measured in seconds under a slit lamp biomicroscope with a yellow filter offering cobalt blue light. The mean value of three repeated measurement results are used	4, 12 weeks after administration
Hyperemia score	Prior to fluorescein staining, hyperemia evaluation is done to the bulbar conjunctiva and the limbus, the border between cornea and conjunctiva using Efron Grading Scales. grade 0: normal; grade 1: trace; grade 2: mild; grade 3: moderate; grade 4: severe (The scales from grade 0 to 4, with higer scales indicate greater severity of symptoms.)	4, 12 weeks after administration

Collaborators and Investigators

• Sponsor: CHA University
• Collaborators: Hanlim Pharm. Co., Ltd.
• Investigators: Principal Investigator: Seungsoo Rho, MD, PhD, CHA Bundang Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Pharmaceutical Solutions; Timolol; Brimonidine Tartrate; Ophthalmic Solutions; Maleic acid; Brimonidine Tartrate, Timolol Maleate Drug Combination
• Other Study ID Numbers: BCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No