Glaucoma
Conditions
Keywords
glaucoma, intraocular pressure, ocular surface, benzalkonium chloride
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.
Interventions
DRUGTafluprost
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
DRUGLatanoprost
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
Sponsors
Paolo Fogagnolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Italy
Contacts
Primary ContactLuca Rossetti, MD
Outcome results
None listed