Overview

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

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
FinnMedi Oy
Collaborators:
Tampere University
The Laboratory and Pharmacy Public Utility of the Pirkanmaa Hospital District
University of Tampere
Treatments:
Latanoprost
Ophthalmic Solutions
Tetrahydrozoline
Criteria
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