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

Santen Oy0 sites150 target enrollmentOctober 3, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ocular hypertension or open angle glaucoma patients are enrolled into this trial.
Sponsor: Santen Oy
Enrollment: 150
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

October 3, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 primary open\-angle glaucoma in one or both eyes, for which the patient has been regularly using latanoprost 0\.0015% (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

•9\.3\.3Exclusion 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 capsular\-, pigmentary\- or angle\-closure 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