Switching From Preserved to Preserved-free Treatments for Glaucoma.

• Status: Unknown status
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paolo Fogagnolo
• Treatments: Latanoprost

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).