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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Monoprost
Xalatan
Sponsored by
CHA University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHA University Bundang Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Monoprost (preservative-free latanoprost eye drop)

Xalatan (preserved latanoprost eye drop)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)
Ocular surface disease index (OSDI)
The ocular surface was assessed using OSDI scoring questionnaire (0 to 100, the higher the worse)
Compliance check
Compliance of the drug administration has been check through the subject's self description (0 to 100, the higher the better)

Secondary Outcome Measures

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)
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)
Ocular surface disease indext (OSDI)
The ocular surface was assessed using OSDI scoring questionnaire(0 to 100, the higher the worse)
IOP (intraocular pressure)
IOP was measured using Goldmann applanation tonometry and measured in mmHg. (numerical)
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)
Limbal and bulbar hyperemia
The conjunctival hyperemia was assessed using Efron grading scales (0 to 4, the higher the worse)

Full Information

First Posted
January 26, 2021
Last Updated
February 4, 2021
Sponsor
CHA University
Collaborators
Samil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04743622
Brief Title
Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost
Official Title
Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
June 23, 2020 (Actual)
Study Completion Date
September 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHA University
Collaborators
Samil Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
Detailed Description
Not provided

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monoprost (preservative-free latanoprost eye drop)
Arm Type
Experimental
Arm Description
latanoprost : 1 drop once a day for 12 weeks to target eyes
Arm Title
Xalatan (preserved latanoprost eye drop)
Arm Type
Active Comparator
Arm Description
latanoprost : 1 drop once a day for 12 weeks to target eyes
Intervention Type
Drug
Intervention Name(s)
Monoprost
Other Intervention Name(s)
Preservative-free latanoprost
Intervention Description
preservative-free latanoprost 1 drop once a day for 12 weeks to target eyes
Intervention Type
Drug
Intervention Name(s)
Xalatan
Other Intervention Name(s)
Preserved latanoprost
Intervention Description
preserved latanoprost 1 drop once a day for 12 weeks to target eyes
Primary Outcome Measure Information:
Title
Corneal staining test
Description
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)
Time Frame
(12-week-point)
Title
Conjunctival staining test
Description
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)
Time Frame
(12-week-point)
Title
Ocular surface disease index (OSDI)
Description
The ocular surface was assessed using OSDI scoring questionnaire (0 to 100, the higher the worse)
Time Frame
(12-week-point)
Title
Compliance check
Description
Compliance of the drug administration has been check through the subject's self description (0 to 100, the higher the better)
Time Frame
(12-week-point)
Secondary Outcome Measure Information:
Title
Corneal staining test
Description
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)
Time Frame
(4-week-point)
Title
Conjunctival staining test
Description
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)
Time Frame
(4-week-point)
Title
Ocular surface disease indext (OSDI)
Description
The ocular surface was assessed using OSDI scoring questionnaire(0 to 100, the higher the worse)
Time Frame
(4-week-point)
Title
IOP (intraocular pressure)
Description
IOP was measured using Goldmann applanation tonometry and measured in mmHg. (numerical)
Time Frame
(4- / 12-week-point)
Title
Tear break up time (TBUT)
Description
The time taken from the last blink to the appearance of a black spot on the cornea after fluorescein dye staining. (second, numerical)
Time Frame
(4- / 12-week-point)
Title
Limbal and bulbar hyperemia
Description
The conjunctival hyperemia was assessed using Efron grading scales (0 to 4, the higher the worse)
Time Frame
(4- / 12-week-point)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seungsoo Rho, MD, PhD
Organizational Affiliation
CHA Bundang Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA University Bundang Medical Center
City
Seongnam
State/Province
Bundang-gu
ZIP/Postal Code
13497
Country
Korea, Republic of

12. IPD Sharing Statement

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

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