NCT01087671CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Santen Oy
- Enrollment
- 185
- Primary Endpoint
- Assessment of changes in ocular symptoms and signs
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Other
Intervention: tafluprost (Drug)
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).
Secondary Outcomes
- Secondary outcome measures include the assessment of safety and quality of life parameters.(From Screening (visit 1) to 12 weeks)
Investigators
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