The Effects of Preservative-free Prostaglandin Eye Drops in Sign and Symptoms on the Eyes of Patients With Glaucoma

Study Overview
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Brief Summary
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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.

Detailed Description
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Primary outcome measures: Change from screening in corneal confocal microscopic findings at month 12 Change from screening in ocular symptoms upon non-instillation at month 12 Change from screening in ocular signs at month 12 Safety and QoL variables: Descriptive statistics, identification of change(s) from screening

Official Title
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An Open-label, Phase IV, Pilot Study, to Evaluate Confocal Microscopic Findings of Cornea, Ocular Signs and Symptoms in Patients With OH or OAG Switching From Latanoprost 0.005% to Preservative Free Tafluprost 0.0015% Eye Drops

Conditions
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Ocular Hypertension, Open-Angle Glaucoma

Intervention / Treatment
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* Drug: Tafluprost 0.0015%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tafluprost 0.0015%<br>Open, one arm study. Patients who have been using latanoprost 0.005% eye drops (Xalatan®) 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 to the assigned preservative-free tafluprost 0.0015% (Taflotan®)eye drops for twelve (12) months. | Drug: Tafluprost 0.0015%<br>* Eye Drops, Solution. Topical Use. One single-unit dose pipet of 0.3 ml solution including 0.0015 mg/ ml of Tafluprost once daily in the affected eye(s)for 12 months.<br>* Other names: Saflutan Conserveermiddelvrij®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from screening in corneal confocal microscopic findings at month 12 |  | Baseline and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from screening in ocular symptoms and signs upon non-instillation |  | Baseline and Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Confocal microscopic findings, Ocular Hypertension, Open-Angle Glaucoma, Preservative-free eye drops