Status:
UNKNOWN
Switching From Preserved to Preserved-free Treatments for Glaucoma.
Lead Sponsor:
Paolo Fogagnolo
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 (latan...
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 foll...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01433900
Start Date
May 1 2012
End Date
June 1 2014
Last Update
May 16 2014
Active Locations (1)
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1
San Paolo Hospital
Milan, Italy, 20142