Glaucoma, Ocular Hypertensive
Conditions
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.
Interventions
DRUGBRIDIN-plus Eye drops
BRIDIN-plus Eye drops
DRUGCombigan Eye drops
Combigan Eye drops
Sponsors
Hanlim Pharm. Co., Ltd.
CHA University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal staining test | 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.) |
| Conjunctival staining test | 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. |
| Ocular surface disease index (OSDI) | 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 |
| Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance) | 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
| Measure | Time frame | Description |
|---|---|---|
| Tear break up time (TBUT) | 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 |
| Corneal staining test | 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.) |
| Hyperemia score | 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.) |
| Conjunctival staining test | 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. |
| Ocular surface disease index (OSDI) | 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 |
| IOP(Intraocular pressure) | 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. |
Countries
South Korea
Outcome results
None listed