Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost
- Registration Number
- NCT04743622
- Lead Sponsor
- CHA University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- IOP >/= 15mmHg and < 40 mmHg in each eye using Goldmann applanation tonometry at visit 2
- Written consent voluntarily to participate in this clinical trial
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Monoprost (preservative-free latanoprost eye drop) Monoprost latanoprost : 1 drop once a day for 12 weeks to target eyes Xalatan (preserved latanoprost eye drop) Xalatan latanoprost : 1 drop once a day for 12 weeks to target eyes
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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)
IOP (intraocular pressure) (4- / 12-week-point) IOP was measured using Goldmann applanation tonometry and measured in mmHg. (numerical)
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)
Limbal and bulbar hyperemia (4- / 12-week-point) The conjunctival hyperemia was assessed using Efron grading scales (0 to 4, 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)
Trial Locations
- Locations (1)
CHA University Bundang Medical Center
🇰🇷Seongnam, Bundang-gu, Korea, Republic of