Comparison of Different Drugs on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study

May 17, 2021 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Drug: Lumigan PF; Xalatan
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.
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).
Drug: Lumigan PF; Xalatan
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.
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patients
Time Frame: Change from Baseline OSDI at 1 month
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
Change from Baseline OSDI at 4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2019

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201908054RINC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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