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.
- Conditions
- Patient with ocular hypertension or patients with open angle glaucoma are enrolled into this trial.MedDRA version: 9.1Level: LLTClassification code 10030348Term: Open angle glaucomaMedDRA version: 9.1Level: LLTClassification code 10030043Term: Ocular hypertension
- Registration Number
- EUCTR2007-004872-37-DE
- Lead Sponsor
- Santen Oy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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 0.0015% (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
OR
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
•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
4.A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes
5.Are willing to follow instructions
6.Have provided a written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
11.Current alcohol or drug abuse
12.Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days
1 A reliable method of contraception is defined as sterilization or those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to investigate whether changes in ocular signs, symptoms and conjunctival inflammatory markers occur when patients are switched from latanoprost 0.005% eye drops with preservative to tafluprost 0.0015% eye drops without preservative.;Secondary Objective: ;Primary end point(s): - Change from screening in ocular symptoms upon non-instillation at week 6 and 12<br>- Change from screening in ocular signs at week 6 and 12<br>- Change from screening in conjunctival inflammatory marker parameters at week 6 and 12
- Secondary Outcome Measures
Name Time Method