Clinical trial NCT01433900: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glaucoma
Keywords: glaucoma
intraocular pressure
ocular surface
benzalkonium chloride
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants
timeFrame: Month 3, 6, 9, 12
Secondary outcomes:
measure: Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity)
timeFrame: Months 3, 6, 9 ,12
measure: Changes in density of epithelial cells, Langerhans cells, endothelial cells
timeFrame: Month 3, 6, 9 ,12
measure: Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test)
timeFrame: Month 3, 6, 9, 12
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Paolo Hospital
Study officials:
affiliation: San Paolo Hospital, Milan, Italy
name: Luca Rossetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.