Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost to Preservative Free Tafluprost Eye Drops
- Registration Number
- NCT01087671
- Lead Sponsor
- Santen Oy
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-lable study with one arm tafluprost -
- Primary Outcome Measures
Name Time Method Assessment of changes in ocular symptoms and signs 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 Outcome Measures
Name Time Method Secondary outcome measures include the assessment of safety and quality of life parameters. 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.