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

Ocular Hypertension Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01369771
Study type Interventional
Source FinnMedi Oy
Contact
Status Completed
Phase Phase 4
Start date August 2010
Completion date June 2012
View Details
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