Switching From Preserved to Preserved-free Treatments for Glaucoma.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Tafluprost
* Drug: Latanoprost


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tafluprost<br>1 drop of tafluprost to eligible eye(s) once daily (at 9 pm) | Drug: Tafluprost<br>* 1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)<br>|
| Active Comparator: Latanoprost<br>1 drop of latanoprost to eligible eye(s) once daily (at 9 pm) | Drug: Latanoprost<br>* 1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | Month 3, 6, 9, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, intraocular pressure, ocular surface, benzalkonium chloride