Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost to Preservative Free Tafluprost Eye Drops

The purpose of this study is to investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (Xalatan) to preservative free Tafluprost eye drops.

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Open-angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication.
Evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.

Treatment and study plan

tafluprost

Drug

prostaglandin analogue

Primary outcomes

Assessment of changes in ocular symptoms and signs

Time frame: From Screening (Visit 1) to12 weeks.

Ocular symptoms include: irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation.

Following signs will be evaluated: tear break-up time, corneal and conjunctival fluorescein staining, blepharitis, conjunctival redness and tear secretion (schirmer test).

Secondary outcomes

Secondary outcome measures include the assessment of safety and quality of life parameters.

Time frame: From Screening (visit 1) to 12 weeks

Safety parameters include: best-corrected visual acuity, biomicroscopy, ophthalmoscopy, visual field test, drop discomfort upon instillation, intra ocular pressure, quality of life and adverse events.

Sponsors and collaborators

Lead sponsor

Santen Oy

Industry

Registry information

Official study title

Ocular Signs and Symptoms in Patients With Ocular Hypertension or Open-angle Glaucoma Switched From Preserved Latanoprost 0.005% Eye Drops to Preservative Free Tafluprost Eye Drops

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Mar 16, 2010
Registry last updated: May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed