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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by FinnMedi Oy.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Tampere
The Laboratory and Pharmacy Public Utility of the Pirkanmaa Hospital District
Information provided by:
FinnMedi Oy
ClinicalTrials.gov Identifier:
NCT01369771
First received: July 5, 2010
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Ocular Hypertension
Open-Angle Glaucoma
Drug: Tafluprost 0.0015%
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by FinnMedi Oy:

Primary Outcome Measures:
  • Change from screening in corneal confocal microscopic findings at month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from screening in ocular symptoms and signs upon non-instillation [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369771

Contacts
Contact: Hannu Uusitalo, MD, PhD +358-500-595 232 hannu.uusitalo@uta.fi
Contact: Minna Parkkari, MD +358-5060849 minna.parkkari@uta.fi

Locations
Finland
FinnMedi Oy, Clinical Trial Center Recruiting
Tampere, Pirkanmaa district, Finland, 33520
Contact: Pirkko Lepola, MSc.    +358-50-5142646    pirkko.lepola@finnmedi.com   
Principal Investigator: Hannu Uusitalo, MD, PhD         
Sub-Investigator: Minna Parkkari, MD         
Sponsors and Collaborators
FinnMedi Oy
University of Tampere
The Laboratory and Pharmacy Public Utility of the Pirkanmaa Hospital District
Investigators
Principal Investigator: Hannu Uusitalo, MD, PhD Clinical Trial Center, FinnMedi Oy
  More Information

No publications provided

Responsible Party: Hannu Uusitalo, Professor of Ophthalmology, Tampere University, Faculty of Medicine, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01369771     History of Changes
Other Study ID Numbers: S001-2010, 2010-021039-14
Study First Received: July 5, 2010
Last Updated: June 8, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by FinnMedi Oy:
Confocal microscopic findings
Ocular Hypertension
Open-Angle Glaucoma
Preservative-free eye drops

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Signs and Symptoms
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Ophthalmic Solutions
Tetrahydrozoline
Autonomic Agents
Cardiovascular Agents
Nasal Decongestants
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 23, 2014