Back to resultsComparison of Efficacy and Ocular Surface Assessment Between BRIDIN-plus and Combigan in Glaucoma or Ocular Hypertensive (BCT)
Primary Purpose
Glaucoma, Ocular Hypertensive
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BRIDIN-plus Eye drops
Combigan Eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
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
Sites / Locations
- Seungsoo Rho
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BRIDIN-plus Eye drops
Combigan Eye drops
Arm Description
One drop in the eyes, twice a day, approximately 12 hours apart.
One drop in the eyes, twice a day, approximately 12 hours apart.
Outcomes
Primary Outcome Measures
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.)
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.
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
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.
Secondary Outcome Measures
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.)
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.
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
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.
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
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.)
Full Information
NCT ID
NCT06078592
First Posted
July 19, 2023
Last Updated
October 9, 2023
Sponsor
CHA University
Collaborators
Hanlim Pharm. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT06078592
Brief Title
Comparison of Efficacy and Ocular Surface Assessment Between BRIDIN-plus and Combigan in Glaucoma or Ocular Hypertensive
Acronym
BCT
Official Title
Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN- PLUS® Eye Drops and COMBIGAN® Eye Drops in Glaucoma or Ocular Hypertensive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHA University
Collaborators
Hanlim Pharm. Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertensive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BRIDIN-plus Eye drops
Arm Type
Experimental
Arm Description
One drop in the eyes, twice a day, approximately 12 hours apart.
Arm Title
Combigan Eye drops
Arm Type
Active Comparator
Arm Description
One drop in the eyes, twice a day, approximately 12 hours apart.
Intervention Type
Drug
Intervention Name(s)
BRIDIN-plus Eye drops
Other Intervention Name(s)
Brimonidine tartrate 2.0mg, Timolol maleate 6.8mg(without preservative)
Intervention Description
One drop in the eyes, twice a day, approximately 12 hours apart.
Intervention Type
Drug
Intervention Name(s)
Combigan Eye drops
Other Intervention Name(s)
Brimonidine tartrate 2.0mg, Timolol maleate 6.8mg(with preservative)
Intervention Description
One drop in the eyes, twice a day, approximately 12 hours apart.
Primary Outcome Measure Information:
Title
Corneal staining test
Description
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.)
Time Frame
12 weeks after administration
Title
Conjunctival staining test
Description
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.
Time Frame
12 weeks after administration
Title
Ocular surface disease index (OSDI)
Description
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
Time Frame
12 weeks after administration
Title
Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance)
Description
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.
Time Frame
12 weeks after administration
Secondary Outcome Measure Information:
Title
Corneal staining test
Description
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.)
Time Frame
4 weeks after administration
Title
Conjunctival staining test
Description
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.
Time Frame
4 weeks after administration
Title
Ocular surface disease index (OSDI)
Description
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
Time Frame
4 weeks after administration
Title
IOP(Intraocular pressure)
Description
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.
Time Frame
4, 12 weeks after administration
Title
Tear break up time (TBUT)
Description
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
Time Frame
4, 12 weeks after administration
Title
Hyperemia score
Description
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.)
Time Frame
4, 12 weeks after administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seungsoo Rho, MD, PhD
Organizational Affiliation
CHA Bundang Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seungsoo Rho
City
Seoul
State/Province
Seongnam, Bundang-gu
ZIP/Postal Code
13497
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of Efficacy and Ocular Surface Assessment Between BRIDIN-plus and Combigan in Glaucoma or Ocular Hypertensive
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