Switching From Preserved to Preserved-free Treatments for Glaucoma.

May 15, 2014 updated by: Paolo Fogagnolo

The Advantage of Switching From Preserved to Preserved-free Treatments in Glaucoma. A Clinical and Confocal Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20142
        • Recruiting
        • San Paolo Hospital
        • Principal Investigator:
          • Paolo Fogagnolo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Month 3, 6, 9, 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paolo Fogagnolo

Investigators

  • Principal Investigator: Luca Rossetti, MD, San Paolo Hospital, Milan, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

September 12, 2011

First Posted (ESTIMATE)

September 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSD-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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