the effects of preservative-free prostaglandin eye drops in sign and symptoms on the eyes of patients with glaucoma

Conditions: Ocular Hypertension; Open-Angle Glaucoma

Summary: the objective of this study is to investigate corneal confocal microscopic findings, ocular signs and symptoms in patients on treatment with the preserved prostaglandin analogue latanoprost 0.005% eye drops (xalatan®) and after the switch to preservative-free prostaglandin analog tafluprost 0.0015% eye drops (taflotan®). patients who have been using latanoprost as their prior medication (at least 6 months) and who fulfil all the inclusion criteria including the specified ocular symptoms and signs, will switch from latanoprost 0.005% eye drops to the assigned preservative-free tafluprost 0.0015% eye drops for twelve (12) months.

primary outcome measures: 1. change from screening in corneal confocal microscopic findings at month 12 2. change from screening in ocular symptoms upon non-instillation at month 12 3. change from screening in ocular signs at month 12 safety and qol variables: 4. descriptive statistics, identification of change(s) from screening

Eligibility criteria:
inclusion criteria: * have provided a written informed consent * aged 18 years or more * a diagnosis of ocular hypertension or open-angle glaucoma (either poag or capsular glaucoma) in one or both eyes, for which the patient has been regularly using latanoprost 0.005% (xalatan®) for at least six months before screening (confirmed in anamnesis) * in the screening visit evaluation, the presence of: at least two ocular symptoms considered for the two eyes together (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye sensation) of at least mild severity (grade ≥ 2) upon non-instillation or one ocular symptom of at least mild severity (grade ≥ 2) upon non-instillation and at least one of the following ocular signs in either eye with prior treatment: fluorescein tear break-up time (fbut): less than 10 seconds corneal and conjunctival fluorescein staining: corneal fluorescein staining score of at least grade i or combined nasal and temporal staining scores of at least grade ii blepharitis: of at least mild severity (grade ≥ 1) conjunctival redness/hyperemia: of at least mild severity (grade 1) tear production: 10 mm or less on schirmer test * a best corrected etdrs visual acuity score of +0.6 logmar or better in both eyes * negative pregnancy test result at the screening visit, or, consistently and correctly used reliable method of contraception during the study * are willing to follow instructions exclusion criteria: * females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception * anterior chamber angle in either eye to be treated less than grade 2 according to schaffer classification as measured by gonioscopy * any corneal abnormality or other condition preventing reliable applanation tonometry, including prior refractive eye surgery * iop greater than 22 mmhg at 15:00 iop measurement in either eye at screening/baseline visit * use of preserved eye drops (other than latanoprost) including artificial tears at screening or within two weeks prior to screening visit * diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular glaucoma in either eye * suspected contraindication to tafluprost therapy (hypersensitivity to tafluprost or any of the excipients) * glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to screening in eye(s) to be treated with study medication * use of contact lenses at screening or during the study * any ocular (e.g. aphakia, pseudophakia with torn posterior lens capsule2 or anterior chamber lenses,known risk factors for cystoid macular oedema or iritis/uveitis), systemic or psychiatric disease/condition (e.g.uncontrolled arterial hypertension, diabetes) that may put the patient at a significant risk or may confound the study results or may interfere significantly with the patient's participation in the study as judged by the investigator * current alcohol or drug abuse * current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days

Keywords: confocal microscopic findings ocular hypertension open-angle glaucoma preservative-free eye drops