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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04743622
• Other study ID #: MIT 2019-02-020
• Status: Completed
• Phase: Phase 4
• Start date: April 30, 2019
• Est. completion date: September 13, 2020

Study information

• Verified date: February 2021
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Not provided

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 13, 2020
• Est. primary completion date: June 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• Monoprost
preservative-free latanoprost 1 drop once a day for 12 weeks to target eyes
• Xalatan
preserved latanoprost 1 drop once a day for 12 weeks to target eyes

Locations

Country	Name	City	State
Korea, Republic of	CHA University Bundang Medical Center	Seongnam	Bundang-gu

Sponsors (2)

Lead Sponsor	Collaborator
CHA University	Samil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Ocular surface disease index (OSDI)	The ocular surface was assessed using OSDI scoring questionnaire (0 to 100, the higher the worse)	(12-week-point)
Primary	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	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)
Secondary	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)
Secondary	Ocular surface disease indext (OSDI)	The ocular surface was assessed using OSDI scoring questionnaire(0 to 100, the higher the worse)	(4-week-point)
Secondary	IOP (intraocular pressure)	IOP was measured using Goldmann applanation tonometry and measured in mmHg. (numerical)	(4- / 12-week-point)
Secondary	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)
Secondary	Limbal and bulbar hyperemia	The conjunctival hyperemia was assessed using Efron grading scales (0 to 4, the higher the worse)	(4- / 12-week-point)