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Switching From Preserved to Preserved-free Treatments for Glaucoma.

Primary Purpose

Glaucoma

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Tafluprost

Latanoprost

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, intraocular pressure, ocular surface, benzalkonium chloride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

San Paolo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Tafluprost

Latanoprost

Arm Description

1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)

1 drop of latanoprost to eligible eye(s) once daily (at 9 pm)

Outcomes

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

Secondary Outcome Measures

Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity)

Changes in density of epithelial cells, Langerhans cells, endothelial cells

Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test)

Full Information

NCT ID

NCT01433900

First Posted

July 25, 2011

Last Updated

May 15, 2014

Sponsor

Paolo Fogagnolo

1. Study Identification

Unique Protocol Identification Number

NCT01433900

Brief Title

Switching From Preserved to Preserved-free Treatments for Glaucoma.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Paolo Fogagnolo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

glaucoma, intraocular pressure, ocular surface, benzalkonium chloride

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tafluprost

Arm Type

Active Comparator

Arm Description

1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)

Arm Title

Latanoprost

Arm Type

Active Comparator

Arm Description

1 drop of latanoprost to eligible eye(s) once daily (at 9 pm)

Intervention Type

Drug

Intervention Name(s)

Tafluprost

Intervention Description

1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)

Intervention Type

Drug

Intervention Name(s)

Latanoprost

Intervention Description

1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity)

Time Frame

Months 3, 6, 9 ,12

Title

Changes in density of epithelial cells, Langerhans cells, endothelial cells

Time Frame

Month 3, 6, 9 ,12

Title

Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test)

Time Frame

Month 3, 6, 9, 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luca Rossetti, MD

Phone

+390281844401

luca.rossetti@unimi.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luca Rossetti, MD

Organizational Affiliation

San Paolo Hospital, Milan, Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Paolo Hospital

City

Milano

ZIP/Postal Code

20142

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luca Rossetti, MD

First Name & Middle Initial & Last Name & Degree

Paolo Fogagnolo, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

25893514

Citation

Fogagnolo P, Dipinto A, Vanzulli E, Maggiolo E, De Cilla' S, Autelitano A, Rossetti L. A 1-year randomized study of the clinical and confocal effects of tafluprost and latanoprost in newly diagnosed glaucoma patients. Adv Ther. 2015 Apr;32(4):356-69. doi: 10.1007/s12325-015-0205-5. Epub 2015 Apr 19.

Results Reference

derived

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Switching From Preserved to Preserved-free Treatments for Glaucoma.

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