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

NCT01369771 | Completed Phase 4

• 2 other identifiers: S001-20102010-021039-14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ocular Hypertension; Open-Angle Glaucoma

Keywords

Confocal microscopic findings; Ocular Hypertension; Open-Angle Glaucoma; Preservative-free eye drops

Outcome Measures

Primary Outcomes (1)

• Change from screening in corneal confocal microscopic findings at month 12

  Baseline and Month 12

Secondary Outcomes (1)

• Change from screening in ocular symptoms and signs upon non-instillation

  Baseline and Month 12

Study Arms (1)

Tafluprost 0.0015%

EXPERIMENTAL

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%

Interventions

Tafluprost 0.0015% DRUG

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.

Also known as: Taflotan®, Taflotan sine®, Saflutan®, Saflutan Conserveermiddelvrij®

Tafluprost 0.0015%

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FinnMedi Oy: lead
• Tampere University: collaborator
• The Laboratory and Pharmacy Public Utility of the Pirkanmaa Hospital District: collaborator

Study Sites (1)

FinnMedi Oy, Clinical Trial Center

Tampere, Pirkanmaa District, 33520, Finland

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Interventions

tafluprost

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Study Officials

• Hannu Uusitalo, MD, PhD

  Clinical Trial Center, FinnMedi Oy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2010
• First Posted: June 9, 2011
• Study Start: August 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

FI (1)