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Switching From Preserved to Preserved-free Treatments for Glaucoma.

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ClinicalTrials.gov Identifier: NCT01433900
Recruitment Status : Unknown
Verified September 2011 by Paolo Fogagnolo, University of Milan.
Recruitment status was:  Recruiting
First Posted : September 14, 2011
Last Update Posted : May 16, 2014
Information provided by (Responsible Party):
Paolo Fogagnolo, University of Milan

Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma Drug: Tafluprost Drug: Latanoprost Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Advantage of Switching From Preserved to Preserved-free Treatments in Glaucoma. A Clinical and Confocal Study.
Study Start Date : May 2012
Primary Completion Date : May 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433900

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paolo Fogagnolo, Prof. Luca Rossetti, University of Milan
ClinicalTrials.gov Identifier: NCT01433900     History of Changes
Other Study ID Numbers: MSD-007
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: September 2011

Keywords provided by Paolo Fogagnolo, University of Milan:
intraocular pressure
ocular surface
benzalkonium chloride

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Antihypertensive Agents