GlaucomaPhase 4NCT04743622
Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost
A Phase 4 study testing Monoprost and Xalatan in people with Glaucoma and Ocular Hypertension, run by CHA University at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Monoprost and Xalatan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Apr 2019to 13 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IOP >/= 15mmHg and < 40 mmHg in each eye using Goldmann applanation tonometry at visit 2
- Written consent voluntarily to participate in this clinical trial
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA University Bundang Medical Center
Seongnam, Bundang-gu, 13497
About this study
Official title: 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
Read the detailed description
Not provided
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Monoprost, Xalatan
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonoprostDrug
Also called Preservative-free latanoprost
preservative-free latanoprost 1 drop once a day for 12 weeks to target eyes
XalatanDrug
Also called Preserved latanoprost
preserved latanoprost 1 drop once a day for 12 weeks to target eyes
| Study group | Role | What they receive |
|---|---|---|
| Monoprost (preservative-free latanoprost eye drop) | Experimental | latanoprost : 1 drop once a day for 12 weeks to target eyes Receives: Drug: Monoprost |
| Xalatan (preserved latanoprost eye drop) | Active comparator | latanoprost : 1 drop once a day for 12 weeks to target eyes Receives: Drug: Xalatan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: (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)
Measured: (12-week-point)
Ocular surface disease index (OSDI)
The ocular surface was assessed using OSDI scoring questionnaire (0 to 100, the higher the worse)
Measured: (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)
Measured: (12-week-point)
Secondary outcomes (6)
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)
Measured: (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)
Measured: (4-week-point)
Ocular surface disease indext (OSDI)
The ocular surface was assessed using OSDI scoring questionnaire(0 to 100, the higher the worse)
Measured: (4-week-point)
IOP (intraocular pressure)
IOP was measured using Goldmann applanation tonometry and measured in mmHg. (numerical)
Measured: (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)
Measured: (4- / 12-week-point)
Limbal and bulbar hyperemia
The conjunctival hyperemia was assessed using Efron grading scales (0 to 4, the higher the worse)
Measured: (4- / 12-week-point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start30 Apr 2019
- Primary completion23 Jun 2020
- Study completion13 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Collaborators
- Samil Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Seungsoo Rho, MD, PhD, Principal investigator, CHA Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743622
- Sponsor's protocol ID
- MIT 2019-02-020
- Status last verified
- Feb 2021
- First submitted
- 26 Jan 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04743622
- Acronym / sponsor ID
- MIT 2019-02-020
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Collaborators
- Samil Pharmaceutical Co., Ltd.
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 13 Sep 2020 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monoprost (preservative-free latanoprost eye drop) | Experimental | Drug: Monoprostlatanoprost : 1 drop once a day for 12 weeks to target eyes |
| Xalatan (preserved latanoprost eye drop) | Active comparator | Drug: Xalatanlatanoprost : 1 drop once a day for 12 weeks to target eyes |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IOP >/= 15mmHg and < 40 mmHg in each eye using Goldmann applanation tonometry at visit 2
- Written consent voluntarily to participate in this clinical trial
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonoprostAlso: Preservative-free latanoprostpreservative-free latanoprost 1 drop once a day for 12 weeks to target eyes | Drug | Monoprost (preservative-free latanoprost eye drop) |
| XalatanAlso: Preserved latanoprostpreserved latanoprost 1 drop once a day for 12 weeks to target eyes | Drug | Xalatan (preserved latanoprost eye drop) |
Primary outcome
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)
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)
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)
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)
6 secondary outcomes
Corneal staining test
Time frame: (4-week-point)
Conjunctival staining test
Time frame: (4-week-point)
Ocular surface disease indext (OSDI)
Time frame: (4-week-point)
IOP (intraocular pressure)
Time frame: (4- / 12-week-point)
Tear break up time (TBUT)
Time frame: (4- / 12-week-point)
Limbal and bulbar hyperemia
Time frame: (4- / 12-week-point)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seungsoo Rho, MD, PhD principal investigator
CHA Bundang Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Monoprost and Xalatan in people with Glaucoma and Ocular Hypertension, run by CHA University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal staining test (time frame: (12-week-point)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.