Switching From Preserved to Preserved-free Treatments for Glaucoma.

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01433900
• Other study ID #: MSD-007
• Status: Recruiting
• Phase: Phase 3
• First received: July 25, 2011
• Last updated: May 15, 2014
• Start date: May 2012
• Est. completion date: June 2014

Study information

• Verified date: September 2011
• Source: University of Milan
• Contact: Luca Rossetti, MD
• Phone: +390281844401
• Email: luca.rossetti[@]unimi.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Tafluprost
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
• Latanoprost
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)

Locations

Country	Name	City	State
Italy	San Paolo Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Paolo Fogagnolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants		Month 3, 6, 9, 12	Yes
Secondary	Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity)		Months 3, 6, 9 ,12	Yes
Secondary	Changes in density of epithelial cells, Langerhans cells, endothelial cells		Month 3, 6, 9 ,12	Yes
Secondary	Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test)		Month 3, 6, 9, 12	Yes