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

Comparison of Benzalkonium Chloride-containing Latanoprost and Preservative-free Bimatoprost on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04896125
Enrollment
300
Registered
2021-05-21
Start date
2019-10-02
Completion date
2022-08-31
Last updated
2021-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma; Ocular Disorders (I.E. Caused by Ocular Disorders)

Keywords

Benzalkonium chloride, Ocular surface disease, Latanoprost, Bimatoprost

Brief 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.

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.

Interventions

DRUGLumigan 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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patientsChange from Baseline OSDI at 1 month

Countries

Taiwan

Contacts

Primary ContactChien-Chia Su, MD
chienchiasu@ntu.edu.tw+886-2312-3456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026