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

CHA University57 enrolled

Overview

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

Not provided

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Glaucoma Ocular Hypertension

Interventions

MonoprostDRUG

preservative-free latanoprost 1 drop once a day for 12 weeks to target eyes

XalatanDRUG

preserved latanoprost 1 drop once a day for 12 weeks to target eyes

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

CHA University Bundang Medical Center

Seongnam, Bundang-gu, South Korea

Outcomes

Primary Outcomes

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)

Time frame: (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)

Time frame: (12-week-point)

Ocular surface disease index (OSDI)

The ocular surface was assessed using OSDI scoring questionnaire (0 to 100, the higher the worse)

Time frame: (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)

Time frame: (12-week-point)

Secondary Outcomes

Corneal staining test

Time frame: (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)

Time frame: (4-week-point)

Ocular surface disease indext (OSDI)

The ocular surface was assessed using OSDI scoring questionnaire(0 to 100, the higher the worse)

Data from ClinicalTrials.gov

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