Ocular Hypertension, Open-Angle Glaucoma
Conditions
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.
Interventions
DRUGtafluprost
prostaglandin analogue
Sponsors
Santen Oy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed