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Completed

NCT Number: NCT06078592

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seungsoo Rho

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BRIDIN-plus Eye drops

Drug

BRIDIN-plus Eye drops

Other names: Brimonidine tartrate 2.0mg, Timolol maleate 6.8mg(without preservative)

Combigan Eye drops

Drug

Combigan Eye drops

Other names: Brimonidine tartrate 2.0mg, Timolol maleate 6.8mg(with preservative)

Primary outcomes

  1. Corneal staining test

    Time frame: 12 weeks after administration

    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.)

  2. Conjunctival staining test

    Time frame: 12 weeks after administration

    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.

  3. Ocular surface disease index (OSDI)

    Time frame: 12 weeks after administration

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

    Time frame: 12 weeks after administration

    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 outcomes

  1. Corneal staining test

    Time frame: 4 weeks after administration

    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.)

  2. Conjunctival staining test

    Time frame: 4 weeks after administration

    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.

  3. Ocular surface disease index (OSDI)

    Time frame: 4 weeks after administration

    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. IOP(Intraocular pressure)

    Time frame: 4, 12 weeks after administration

    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.

  5. Tear break up time (TBUT)

    Time frame: 4, 12 weeks after administration

    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

  6. Hyperemia score

    Time frame: 4, 12 weeks after administration

    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.)

Sponsors and collaborators

Lead sponsor

CHA University

Other

Collaborators

  • Hanlim Pharm. Co., Ltd.

Registry information

Official study title

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

Acronym: BCT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2023
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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