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

Santen Oy0 sites185 target enrollmentApril 2010

ConditionsOcular Hypertension Open-Angle Glaucoma

Interventionstafluprost

Drugstafluprost

Overview

Phase: Phase 3
Intervention: tafluprost
Conditions: Ocular Hypertension
Sponsor: Santen Oy
Enrollment: 185
Primary Endpoint: Assessment of changes in ocular symptoms and signs
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

October 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Santen Oy

Responsible Party

Sponsor

Eligibility Criteria

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.

Exclusion Criteria

Not provided

Arms & Interventions

Open-lable study with one arm

Intervention: tafluprost

Outcomes

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).