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

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

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: Monoprost; Drug: Xalatan

Detailed Description

Not provided

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang-gu
    • Seongnam, Bundang-gu, Korea, Republic of, 13497
      • CHA University Bundang Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: CHA University
• Collaborators: Samil Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Seungsoo Rho, MD, PhD, CHA Bundang Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): June 23, 2020
• Study Completion (Actual): September 13, 2020

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: MIT 2019-02-020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No