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

• Conditions: Glaucoma; Ocular Disorders (I.E. Caused by Ocular Disorders)
• Interventions: Drug: Lumigan PF; Xalatan

• Registration Number: NCT04896125
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2019-10-02
• Status Verified: 2020-09
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Study First Posted: 2021-05-21
• Last Update Posted: 2021-05-21
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Xalatan	Lumigan PF; 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).
Lumigan PF	Lumigan PF; 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 0.03% bimatoprost (preservative-free) (Lumigan PF, Allergan Inc., CA, USA).

Primary Outcome Measures

Name	Time	Method
The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patients	Change from Baseline OSDI at 4 month

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan