Glaucoma; Ocular Disorders (I.E. Caused by Ocular Disorders)NCT04896125
Comparison of Different Drugs on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study
An observational study of Glaucoma; Ocular Disorders (I.E. Caused by Ocular Disorders), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Participants were randomised to receive benzalkonium chloride-containing latanoprost (Xalatan) or preservative-free bimatoprost (Lumigan). Through this study, the investigators would like to analyze the impact of different antiglaucoma medications on ocular surface disease in glaucoma patients. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma; Ocular Disorders (I.E. Caused by Ocular Disorders)
- What is being tested?
- Lumigan PF; Xalatan
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Oct 2019to 31 Aug 2022
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were considered eligible for enrolment if they were newly diagnosed with glaucoma and started to receive ocular hypotensive eye drops at our clinic.
Who may be able to join
- Patients are not diagnosed with glaucoma and don't receive any ocular hypotensive eye drops at our clinic.
- Patients accept the rules for follow-up visits for at least six months.
Who cannot join
- Patients are with a history of ocular trauma.
- Patients are with contact lens use.
- Patients are diagnosed with secondary glaucoma.
- Patients have significant diseases affecting the meibomian gland and ocular surface.
- Patients have poor IOP control that required additional ocular hypotensive eye drops.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chien-Chia Su, MD, +886 2312 3456 ext. 2131, chienchiasu@ntu.edu.tw
About this study
Official title: Comparison of Benzalkonium Chloride-containing Latanoprost and Preservative-free Bimatoprost on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study
Participants were randomised to receive benzalkonium chloride-containing latanoprost (Xalatan) or preservative-free bimatoprost (Lumigan). Through this study, the investigators would like to analyze the impact of different antiglaucoma medications on ocular surface disease in glaucoma patients.
Read the detailed description
The purpose of our study is to assess the effect of antiglaucoma medication on ocular surface disease in glaucoma patients before and after treatment with different antiglaucoma medication. All included patients are newly diagnosed with glaucoma and received no previous antiglaucoma treatment. Medical records will be collected prospectively from Sep. 15th 2019 to Aug. 31st 2022. The symptoms and signs of ocular surface disease in each individual will be assessed with questionnaire and clinical exams, including the basal Schirmer's test, non-invasive tear film breakup time, meibography, and in vivo confocal microscopy before and at 1, 3, 6 months after treatment.
- Being tested
- Lumigan PF; Xalatan
- Keywords
- Benzalkonium chloride, Ocular surface disease, Latanoprost, Bimatoprost
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumigan PF; XalatanDrug
Lumigan PF: 0.03% bimatoprost (preservative-free) Xalatan: 0.005% latanoprost (containing 0.02% BAK as a preservative) All patients were instructed to use only the given study medication during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Lumigan PF | Patients older than 20 years were recruited from the Glaucoma Clinic of National Taiwan University Hospital. Patients were considered eligible for enrolment if they were newly diagnosed with glaucoma and started to receive ocular hypotensive eye drops at our clinic. Eligible patients then received 0.03% bimatoprost (preservative-free) (Lumigan PF, Allergan Inc., CA, USA). Receives: Drug: Lumigan PF; Xalatan | |
| Xalatan | Patients older than 20 years were recruited from the Glaucoma Clinic of National Taiwan University Hospital. Patients were considered eligible for enrolment if they were newly diagnosed with glaucoma and started to receive ocular hypotensive eye drops at our clinic. Eligible patients then received 0.005% latanoprost (containing 0.02% BAK as a preservative) (Xalatan, Pfizer, NY, USA). Receives: Drug: Lumigan PF; Xalatan | |
| Control | Patients older than 20 years were recruited from the Glaucoma Clinic of National Taiwan University Hospital. Patients were not diagnosed with glaucoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patients
Measured: Change from Baseline OSDI at 1 month
The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patients
Measured: Change from Baseline OSDI at 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start2 Oct 2019
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma; Ocular Disorders (I.E. Caused by Ocular Disorders)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896125
- Sponsor's protocol ID
- 201908054RINC
- Status last verified
- Sep 2020
- First submitted
- 11 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Benzalkonium Chloride-containing Latanoprost and Preservative-free Bimatoprost on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT04896125
- Acronym / sponsor ID
- 201908054RINC
- Keywords
- Benzalkonium chloride, Ocular surface disease, Latanoprost, Bimatoprost
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 21 May 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.
Participants were randomised to receive benzalkonium chloride-containing latanoprost (Xalatan) or preservative-free bimatoprost (Lumigan). Through this study, the investigators would like to analyze the impact of different antiglaucoma medications on ocular surface disease in glaucoma patients.
Detailed description
The purpose of our study is to assess the effect of antiglaucoma medication on ocular surface disease in glaucoma patients before and after treatment with different antiglaucoma medication. All included patients are newly diagnosed with glaucoma and received no previous antiglaucoma treatment. Medical records will be collected prospectively from Sep. 15th 2019 to Aug. 31st 2022. The symptoms and signs of ocular surface disease in each individual will be assessed with questionnaire and clinical exams, including the basal Schirmer's test, non-invasive tear film breakup time, meibography, and in vivo confocal microscopy before and at 1, 3, 6 months after treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumigan PF | – | Drug: Lumigan PF; XalatanPatients older than 20 years were recruited from the Glaucoma Clinic of National Taiwan University Hospital. Patients were considered eligible for enrolment if they were newly diagnosed with glaucoma and started to receive ocular hypotensive eye drops at our clinic. Eligible patients then received 0.03% bimatoprost (preservative-free) (Lumigan PF, Allergan Inc., CA, USA). |
| Xalatan | – | Drug: Lumigan PF; XalatanPatients older than 20 years were recruited from the Glaucoma Clinic of National Taiwan University Hospital. Patients were considered eligible for enrolment if they were newly diagnosed with glaucoma and started to receive ocular hypotensive eye drops at our clinic. Eligible patients then received 0.005% latanoprost (containing 0.02% BAK as a preservative) (Xalatan, Pfizer, NY, USA). |
| Control | – | –Patients older than 20 years were recruited from the Glaucoma Clinic of National Taiwan University Hospital. Patients were not diagnosed with glaucoma. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were considered eligible for enrolment if they were newly diagnosed with glaucoma and started to receive ocular hypotensive eye drops at our clinic.
Key inclusion criteria (2 listed)
- Patients are not diagnosed with glaucoma and don't receive any ocular hypotensive eye drops at our clinic.
- Patients accept the rules for follow-up visits for at least six months.
Key exclusion criteria (5 listed)
- Patients are with a history of ocular trauma.
- Patients are with contact lens use.
- Patients are diagnosed with secondary glaucoma.
- Patients have significant diseases affecting the meibomian gland and ocular surface.
- Patients have poor IOP control that required additional ocular hypotensive eye drops.
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 |
|---|---|---|
| Lumigan PF; XalatanLumigan PF: 0.03% bimatoprost (preservative-free) Xalatan: 0.005% latanoprost (containing 0.02% BAK as a preservative) All patients were instructed to use only the given study medication during the study period. | Drug | Lumigan PF, Xalatan |
Primary outcome
The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patients
Time frame: Change from Baseline OSDI at 1 month
The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patients
Time frame: Change from Baseline OSDI at 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma; Ocular Disorders (I.E. Caused by Ocular Disorders), run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 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: status not confirmed, as of the sponsor's last update on 21 May 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Chia Su, MD (+886-2312-3456 ext. 2131, chienchiasu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patients (time frame: Change from Baseline OSDI at 1 month). The study lists 2 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 21 May 2021.