A phase IIIb study on the changes in ocular signs, symptoms and conjunctival inflammatory markers in patients with ocular hypertension or open-angle glaucoma switched from preserved latanoprost 0.005% eye drops to preservative free tafluprost 0.0015% eye drops.

Santen Oy0 sites150 target enrollmentNovember 27, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Santen Oy
Enrollment: 150
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 27, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Santen Oy

Eligibility Criteria

Inclusion Criteria

•Patients of any race and either sex meeting all of the following criteria will be considered eligible for this study:
•1\.Aged 18 years or more
•2\.A diagnosis of ocular hypertension or open\-angle 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).
•3\.In the Screening visit evaluation, the presence of:
•oAt least two ocular symptoms (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye sensation) of at least mild severity (grade \= 2\) upon non\-instillation and considered for the two eyes together
•oOne 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 AND/OR
•?Combined nasal and temporal staining scores of at least grade II

Exclusion Criteria

•1\.Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception1
•2\.Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy
•3\.Any corneal abnormality or other condition preventing reliable applanation tonometry, including prior refractive eye surgery
•4\.IOP greater than 22 mmHg at 15:00 IOP measurement in either eye at Screening/Baseline visit
•5\.Use of preserved artificial tears at screening or within two weeks prior to screening visit
•6\.Diagnosis of angle\-closure glaucoma or secondary glaucoma other than capsular glaucoma in either eye
•7\.Suspected contraindication to tafluprost therapy (hypersensitivity to tafluprost or any of the excipients).
•8\.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
•9\.Use of contact lenses at Screening or during the study
•10\.Any ocular (e.g. aphakia, pseudophakia with torn posterior lens capsule 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