Switching From Preserved to Preserved-free Treatments for Glaucoma.

Sponsor

Paolo Fogagnolo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01433900

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Anticipated 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 1, 2012

Actual Primary Completion Date :

May 1, 2013

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

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)

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)

Outcome Measures

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 [Month 3, 6, 9, 12]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).