Switching From Preserved to Preserved-free Treatments for Glaucoma.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01433900
• Date of registration: 25/07/2011
• Primary sponsor: Paolo Fogagnolo
• Public title: Switching From Preserved to Preserved-free Treatments for Glaucoma.
• Scientific title: The Advantage of Switching From Preserved to Preserved-free Treatments in Glaucoma. A Clinical and Confocal Study.
• Date of first enrolment: September 2011
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01433900
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Italy

Contacts

• Name: Luca Rossetti, MD
• Affiliation: San Paolo Hospital, Milan, Italy

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Glaucoma

Intervention(s)

Drug: Latanoprost

Drug: Tafluprost

Primary Outcome(s)

Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants [Time Frame: Month 3, 6, 9, 12]

Secondary Outcome(s)

Changes in density of epithelial cells, Langerhans cells, endothelial cells [Time Frame: Month 3, 6, 9 ,12]

Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test) [Time Frame: Month 3, 6, 9, 12]

Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity) [Time Frame: Months 3, 6, 9 ,12]

Secondary ID(s)

MSD-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors