Switching From Preserved to Preserved-free Treatments for Glaucoma.

Paolo Fogagnolo

Status and phase: Unknown; Phase 3

Conditions: Glaucoma

Treatments: Drug: Latanoprost; Drug: Tafluprost

Study type: Interventional

Funder types: Other

Identifiers

NCT01433900

MSD-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Tafluprost

Active Comparator group

Description:

1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)

Treatment:

Drug: Tafluprost

Latanoprost

Active Comparator group

Description:

1 drop of latanoprost to eligible eye(s) once daily (at 9 pm)

Treatment:

Drug: Latanoprost