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

An Open-label, Phase IV, Pilot Study, to Evaluate Confocal Microscopic Findings of Cornea, Ocular Signs and Symptoms in Patients With OH or OAG Switching From Latanoprost 0.005% to Preservative Free Tafluprost 0.0015% Eye Drops

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Tafluprost 0.0015%

Detailed Description

Primary outcome measures:

1. Change from screening in corneal confocal microscopic findings at month 12
2. Change from screening in ocular symptoms upon non-instillation at month 12

3. Change from screening in ocular signs at month 12

   Safety and QoL variables:

4. Descriptive statistics, identification of change(s) from screening

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Pirkanmaa district
    • Tampere, Pirkanmaa district, Finland, 33520
      • FinnMedi Oy, Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tafluprost 0.0015%; Open, one arm study. Patients who have been using latanoprost 0.005% eye drops (Xalatan®) 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 to the assigned preservative-free tafluprost 0.0015% (Taflotan®)eye drops for twelve (12) months.	Drug: Tafluprost 0.0015%; Eye Drops, Solution. Topical Use. One single-unit dose pipet of 0.3 ml solution including 0.0015 mg/ ml of Tafluprost once daily in the affected eye(s)for 12 months.; Other Names: Taflotan®; Taflotan sine®; Saflutan®; Saflutan Conserveermiddelvrij®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from screening in corneal confocal microscopic findings at month 12	Baseline and Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from screening in ocular symptoms and signs upon non-instillation	Baseline and Month 12

Collaborators and Investigators

• Sponsor: FinnMedi Oy
• Collaborators: Tampere University; The Laboratory and Pharmacy Public Utility of the Pirkanmaa Hospital District
• Investigators: Principal Investigator: Hannu Uusitalo, MD, PhD, Clinical Trial Center, FinnMedi Oy

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: July 5, 2010
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (Estimate): June 9, 2011

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 27, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Confocal microscopic findings; Ocular Hypertension; Open-Angle Glaucoma; Preservative-free eye drops
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
• Other Study ID Numbers: S001-2010; 2010-021039-14 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No