Switching From Preserved to Preserved-free Treatments for Glaucoma.
- Registration Number
- NCT01433900
- Lead Sponsor
- Paolo Fogagnolo
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tafluprost Tafluprost 1 drop of tafluprost to eligible eye(s) once daily (at 9 pm) Latanoprost Latanoprost 1 drop of latanoprost to eligible eye(s) once daily (at 9 pm)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
San Paolo Hospital
🇮🇹Milano, Italy
San Paolo Hospital🇮🇹Milano, ItalyLuca Rossetti, MDPrincipal InvestigatorPaolo Fogagnolo, MDPrincipal Investigator