Glaucoma, Ocular Hypertension
Conditions
Brief summary
Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Study
Detailed description
Not provided
Interventions
Sponsors
Samil Pharmaceutical Co., Ltd.
CHA University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* IOP \>/= 15mmHg and \< 40 mmHg in each eye using Goldmann applanation tonometry at visit 2 * Written consent voluntarily to participate in this clinical trial
Exclusion criteria
* Patients with closed-angle, congenital glaucoma or secondary glaucoma caused by steroid drugs, etc. * best-corrected visual acuity 20/80 or less * Patients who have ongoing medical history of ocular inflammation * central corneal thickness is not in between 470um and 591um. * Patients who have received lacrimal duct procedure within the last 3 months or who have plans to have it. * pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal staining test | (12-week-point) | The degree of staining of the cornea after blue fluorescein staining under the light of cobalt blue using a yellow filter was evaluated according to the Oxford grading system (0 to 5, the higher the worse) |
| Conjunctival staining test | (12-week-point) | The conjunctiva was divided into 6 areas and evaluated after the same staining method according to the Oxford grading system (0 to 3, the higher the worse) |
| Ocular surface disease index (OSDI) | (12-week-point) | The ocular surface was assessed using OSDI scoring questionnaire (0 to 100, the higher the worse) |
| Compliance check | (12-week-point) | Compliance of the drug administration has been check through the subject's self description (0 to 100, the higher the better) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear break up time (TBUT) | (4- / 12-week-point) | The time taken from the last blink to the appearance of a black spot on the cornea after fluorescein dye staining. (second, numerical) |
| Corneal staining test | (4-week-point) | The degree of staining of the cornea after blue fluorescein staining under the light of cobalt blue using a yellow filter was evaluated according to the Oxford grading system(0 to 5, the higher the worse) |
| Limbal and bulbar hyperemia | (4- / 12-week-point) | The conjunctival hyperemia was assessed using Efron grading scales (0 to 4, the higher the worse) |
| Conjunctival staining test | (4-week-point) | The conjunctiva was divided into 6 areas and evaluated after the same staining method according to the Oxford grading system (0 to 3, the higher the worse) |
| Ocular surface disease indext (OSDI) | (4-week-point) | The ocular surface was assessed using OSDI scoring questionnaire(0 to 100, the higher the worse) |
| IOP (intraocular pressure) | (4- / 12-week-point) | IOP was measured using Goldmann applanation tonometry and measured in mmHg. (numerical) |
Countries
South Korea
Outcome results
None listed