NCT04743622

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

January 26, 2021

Last Update Submit

February 4, 2021

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Corneal staining test

    (4-week-point)

  • Conjunctival staining test

    (4-week-point)

  • Ocular surface disease indext (OSDI)

    (4-week-point)

  • IOP (intraocular pressure)

    (4- / 12-week-point)

  • Tear break up time (TBUT)

    (4- / 12-week-point)

  • +1 more secondary outcomes

Study Arms (2)

Monoprost (preservative-free latanoprost eye drop)

EXPERIMENTAL

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

Drug: Monoprost

Xalatan (preserved latanoprost eye drop)

ACTIVE COMPARATOR

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

Drug: Xalatan

Interventions

MonoprostDRUG

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

Also known as: Preservative-free latanoprost
Monoprost (preservative-free latanoprost eye drop)
XalatanDRUG

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

Also known as: Preserved latanoprost
Xalatan (preserved latanoprost eye drop)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IOP \>/= 15mmHg and \< 40 mmHg in each eye using Goldmann applanation tonometry at visit 2
  • Written consent voluntarily to participate in this clinical trial

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA University Bundang Medical Center

Seongnam, Bundang-gu, 13497, South Korea

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Seungsoo Rho, MD, PhD

    CHA Bundang Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 8, 2021

Study Start

April 30, 2019

Primary Completion

June 23, 2020

Study Completion

September 13, 2020

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

KR(1)