Switching From Preserved to Preserved-free Treatments for Glaucoma.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Milan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Paolo Fogagnolo, University of Milan
ClinicalTrials.gov Identifier:
NCT01433900
First received: July 25, 2011
Last updated: May 15, 2014
Last verified: September 2011
  Purpose

A 1-year prospective, randomized, investigator-masked trial comparing the confocal and clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.


Condition Intervention Phase
Glaucoma
Drug: Tafluprost
Drug: Latanoprost
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Advantage of Switching From Preserved to Preserved-free Treatments in Glaucoma. A Clinical and Confocal Study.

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants [ Time Frame: Month 3, 6, 9, 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity) [ Time Frame: Months 3, 6, 9 ,12 ] [ Designated as safety issue: Yes ]
  • Changes in density of epithelial cells, Langerhans cells, endothelial cells [ Time Frame: Month 3, 6, 9 ,12 ] [ Designated as safety issue: Yes ]
  • Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test) [ Time Frame: Month 3, 6, 9, 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: June 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tafluprost
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
Drug: Tafluprost
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
Active Comparator: Latanoprost
1 drop of latanoprost to eligible eye(s) once daily (at 9 pm)
Drug: Latanoprost
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)

Detailed Description:

The study protocol comprises 5 visits: baseline, month 3, month 6, month 9, month 12.

At baseline a clinical evaluator will perform a complete ophthalmologic evaluation to confirm diagnosis. The following examinations will be done in the following sequence: anterior segment examination, Shirmer test, Break-up time test. Thereafter, a confocal evaluator will perform confocal microscopy of the central and the peripheral cornea. Finally, contact measurements will be done in the following order: IOP (which will be measured at 3 pm), pachimetry (only at baseline visit) and gonioscony (only at baseline visit). A 15 minutes interval will elapse between two consecutive tests.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is suffering from ocular hypertension, POAG, PEX, NTG. Glaucoma definition is based on the European Glaucoma Society Guidelines.
  • The patient is newly-diagnosed
  • No fluorescein staining at baseline and no observable signs of ocular surface disease
  • No treatment with topical BAK-containing products for at least 6 months
  • Treatment of naïve patients

Exclusion Criteria:

  • Unwilling to sign informed consent
  • Not at least 18 years old
  • Ocular condition that are of safety concern and that can interfere with the study results
  • Closed/barely open anterior chamber angles or history of acute angle closure.
  • Ocular surgery or argon laser trabeculoplasty within the last year. Ocular inflammation/infection occurring within three months prior to pre-trial visit.
  • Presence of the following ocular conditions: KCS, moderate-severe blepharitis, Rosacea, Sjogren syndrome, pterygium, contact lens users.
  • Use of concomitant topical ocular medication that can interfere with study medication
  • Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
  • Any corneal pathology
  • Diabetes at any stage
  • Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement.
  • Refractive surgery patients
  • Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing.
  • Inability to adhere to treatment/visit plan.
  • Have participated in any other clinical trial (i.e., requiring informed consent) within one to three month prior to pre-trial visit (depending on ethics committee decisions).
  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: NCT01433900

Contacts
Contact: Luca Rossetti, MD +390281844401 luca.rossetti@unimi.it

Locations
Italy
San Paolo Hospital Recruiting
Milano, Italy, 20142
Principal Investigator: Luca Rossetti, MD         
Principal Investigator: Paolo Fogagnolo, MD         
Sponsors and Collaborators
Paolo Fogagnolo
Investigators
Principal Investigator: Luca Rossetti, MD San Paolo Hospital, Milan, Italy
  More Information

No publications provided

Responsible Party: Paolo Fogagnolo, Prof. Luca Rossetti, University of Milan
ClinicalTrials.gov Identifier: NCT01433900     History of Changes
Other Study ID Numbers: MSD-007
Study First Received: July 25, 2011
Last Updated: May 15, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
glaucoma
intraocular pressure
ocular surface
benzalkonium chloride

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014