Skip to main content
OpenTrials
Completed

NCT Number: NCT04743622

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 : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Study

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHA University Bundang Medical Center

Seongnam, Bundang-gu, 13497, South Korea

About this study

Not provided

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monoprost

Drug

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

Other names: Preservative-free latanoprost

Xalatan

Drug

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

Other names: Preserved latanoprost

Primary outcomes

  1. Corneal staining test

    Time frame: (12-week-point)

    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)

  2. Conjunctival staining test

    Time frame: (12-week-point)

    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)

  3. Ocular surface disease index (OSDI)

    Time frame: (12-week-point)

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

  4. Compliance check

    Time frame: (12-week-point)

    Compliance of the drug administration has been check through the subject's self description (0 to 100, the higher the better)

Secondary outcomes

  1. Corneal staining test

    Time frame: (4-week-point)

    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)

  2. Conjunctival staining test

    Time frame: (4-week-point)

    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)

  3. Ocular surface disease indext (OSDI)

    Time frame: (4-week-point)

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

  4. IOP (intraocular pressure)

    Time frame: (4- / 12-week-point)

    IOP was measured using Goldmann applanation tonometry and measured in mmHg. (numerical)

  5. Tear break up time (TBUT)

    Time frame: (4- / 12-week-point)

    The time taken from the last blink to the appearance of a black spot on the cornea after fluorescein dye staining. (second, numerical)

  6. Limbal and bulbar hyperemia

    Time frame: (4- / 12-week-point)

    The conjunctival hyperemia was assessed using Efron grading scales (0 to 4, the higher the worse)

Sponsors and collaborators

Lead sponsor

CHA University

Other

Collaborators

  • Samil Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 8, 2021
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.