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

NCT ID: NCT04896125

Last Updated: 2021-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-02

Study Completion Date

2022-08-31

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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Lumigan PF; Xalatan

Intervention Type DRUG

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).

Lumigan PF; Xalatan

Intervention Type DRUG

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chien-Chia Su, MD

Role: CONTACT

+886-2312-3456 ext. 2131

Facility Contacts

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Chien-Chia Su, MD

Role: primary

+886 2312 3456 ext. 2131

Other Identifiers

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201908054RINC

Identifier Type: -

Identifier Source: org_study_id

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