Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost

Study Overview
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Brief Summary
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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
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Not provided

Official Title
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Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Monoprost
* Drug: Xalatan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monoprost (preservative-free latanoprost eye drop)<br>latanoprost : 1 drop once a day for 12 weeks to target eyes | Drug: Monoprost<br>* preservative-free latanoprost 1 drop once a day for 12 weeks to target eyes<br>* Other names: Preservative-free latanoprost;|
| Active Comparator: Xalatan (preserved latanoprost eye drop)<br>latanoprost : 1 drop once a day for 12 weeks to target eyes | Drug: Xalatan<br>* preserved latanoprost 1 drop once a day for 12 weeks to target eyes<br>* Other names: Preserved latanoprost;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining test | 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) | (12-week-point) | 
| Conjunctival staining test | 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) | (12-week-point) | 
| Ocular surface disease index (OSDI) | The ocular surface was assessed using OSDI scoring questionnaire (0 to 100, the higher the worse) | (12-week-point) | 
| Compliance check | Compliance of the drug administration has been check through the subject's self description (0 to 100, the higher the better) | (12-week-point) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining test | 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) | (4-week-point) | 
| Conjunctival staining test | 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) | (4-week-point) | 
| Ocular surface disease indext (OSDI) | The ocular surface was assessed using OSDI scoring questionnaire(0 to 100, the higher the worse) | (4-week-point) | 
| IOP (intraocular pressure) | IOP was measured using Goldmann applanation tonometry and measured in mmHg. (numerical) | (4- / 12-week-point) | 
| Tear break up time (TBUT) | The time taken from the last blink to the appearance of a black spot on the cornea after fluorescein dye staining. (second, numerical) | (4- / 12-week-point) | 
| Limbal and bulbar hyperemia | The conjunctival hyperemia was assessed using Efron grading scales (0 to 4, the higher the worse) | (4- / 12-week-point) |