NCT01369771

The Effects of Preservative-free Prostaglandin Eye Drops in Sign and Symptoms on the Eyes of Patients With Glaucoma

An Open-label, Phase IV, Pilot Study, to Evaluate Confocal Microscopic Findings of Cornea, Ocular Signs and Symptoms in Patients With OH or OAG Switching From Latanoprost 0.005% to Preservative Free Tafluprost 0.0015% Eye Drops

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: FinnMedi Oy · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate corneal confocal microscopic findings, ocular signs and symptoms in patients on treatment with the preserved prostaglandin analogue latanoprost 0.005% eye drops (Xalatan®) and after the switch to preservative-free prostaglandin analog tafluprost 0.0015% eye drops (Taflotan®). Patients who have been using latanoprost as their prior medication (at least 6 months) and who fulfil all the inclusion criteria including the specified ocular symptoms and signs, will switch from latanoprost 0.005% eye drops to the assigned preservative-free tafluprost 0.0015% eye drops for twelve (12) months.

Detailed description

Primary outcome measures: 1. Change from screening in corneal confocal microscopic findings at month 12 2. Change from screening in ocular symptoms upon non-instillation at month 12 3. Change from screening in ocular signs at month 12 Safety and QoL variables: 4. Descriptive statistics, identification of change(s) from screening

Conditions

• Ocular Hypertension
• Open-Angle Glaucoma

Interventions

Type	Name	Description
DRUG	Tafluprost 0.0015%	Eye Drops, Solution. Topical Use. One single-unit dose pipet of 0.3 ml solution including 0.0015 mg/ ml of Tafluprost once daily in the affected eye(s)for 12 months.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-06-09
• Last updated: 2014-10-28

Locations

1 site across 1 country: Finland