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

CHA University

Status and phase: Completed; Phase 4

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Monoprost; Drug: Xalatan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04743622

MIT 2019-02-020

Details and patient eligibility

About

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

Full description

Not provided

Enrollment: 57 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups

Monoprost (preservative-free latanoprost eye drop)

Experimental group

Description:

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

Treatment:

Drug: Monoprost

Xalatan (preserved latanoprost eye drop)

Active Comparator group

Description:

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

Treatment:

Drug: Xalatan