An open-label phase IV study on the changes in ocular signs and symptoms in patients with ocular hypertension or open-angle glaucoma switched from preserved travoprost 0.004% eye drops to preservative free tafluprost 0.0015% eye drops

• Conditions: Patients diagnosed with Ocular Hypertension or Open-angle glaucoma (primary open-angle glaucoma [POAG] or capsular glaucoma); MedDRA version: 12.1Level: LLTClassification code 10030856Term: Open-angle glaucoma; MedDRA version: 12.1Level: LLTClassification code 10030043Term: Ocular hypertension

• Registration Number: EUCTR2010-020746-98-DE
• Lead Sponsor: Santen Oy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Aged 18 years or more
2. 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 travoprost 0.004% (Travatan®) for at least six months before Screening.

3. 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

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 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 eye drops (other than travoprost) including 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 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
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified