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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Lumigan PF; Xalatan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lumigan PF<br>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<br>* 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.<br>|
| Xalatan<br>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<br>* 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.<br>|
| Control<br>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?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benzalkonium chloride, Ocular surface disease, Latanoprost, Bimatoprost