NCT04654611

Tafluprost Preservative Free Switch Study

Ocular Surface Conditions in Asian Glaucoma Patients With Existing Corneal Disorders Switching From Preserved Prostaglandin Analogues Monotherapy to Preservative-free Tafluprost

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Tun Hussein Onn National Eye Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted to document the effect of switching from preserved prostaglandin analogues monotherapy to preservative free tafluprost 0.0015%. The endpoints analyzed are side effect improvement in these patients.

Detailed description

Importance: Glaucoma medications are often preserved with agents such as benzalkonium chloride, which commonly lead to ocular surface diseases. Background: To investigate the effect of switching to a preservative-free prostaglandin analogue, tafluprost 0.0015% on treatment tolerability and ocular surface diseases. Design: This was a prospective, open label, non-randomised, observational study performed in a single hospital. Participants: Patients of Asian descent who have primary open angle glaucoma and ocular hypertension (n = 28), who received preserved prostaglandin monotherapy for longer than 3 months, and has a National Eye Institute ocular surface staining scale score higher than 1. Methods: Patients were switched from preserved prostaglandin monotherapy to preservative-free tafluprost 0.0015%. Patients were analysed at baseline (Visit 0), 1 month (Visit 1) and 3 months (Visit 2). Main Outcome Measures: The main parameter measured is the change in the fluorescein staining score at Visit 2.

Conditions

• Glaucoma
• Primary Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	preservative free tafluprost 0.0015%	preservative free prostaglandin analogue option for treatment of primary open angle glaucoma and ocular hypertension patients

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2020-12-04
• Last updated: 2020-12-04

Locations

1 site across 1 country: Malaysia