Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia40 enrolled

Overview

* Main objective is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements. * Secondary objectives will be the comparison between Latanoprost 0.005% and Tafluprost 0.0015% ophthalmic solution about: * Mean 24-hour IOP values after three months of treatment * IOP values at these time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Primary Open Angle Glaucoma Ocular Hypertension

Interventions

Goldmann and Perkins applanation tonometryDEVICE

IOP values will be assessed by the means of Goldmann or Perkins applanation tonometry at the following time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment

TAFLUPROST 0.0015% EYEDROPSDRUG

Tafluprost 0.0015% preservative-free ophthalmic solution

LATANOPROST 0.005% EYEDROPSDRUG

Latanoprost 0.005% preservative-added ophthalmic solution

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients \> 45 years * Damage of the optic nerve and alterations of the visual field in case of POAG, no defects at the optic nerve and at the visual field in case of OHT * Untreated IOP \> 24 mm Hg but \< 32 mm Hg in at least one eye at baseline (10AM) and central corneal thickness between 500 and 600 μm * Negative pregnancy test (fertile women). Fertile women attending the study must express clear will to avoid pregnancy during all the study period and in the next three months * Informed consent before starting the study Exclusion Criteria: * Secondary glaucoma (Sturge-Weber syndrome, Neurofibromatosis I, neovascular glaucoma, steroid glaucoma, etc) * Anterior segment anomalies (cataract, irido-corneal disgenesy, congenital ectropion uvae, etc) * Past ocular surgery, except cataract surgery in the previous 6 months * Corneal abnormalities that can influence IOP measurements (corneal oedema) * Positive pregnancy test or breast-feeding woman. No will to avoid pregnancy during all the study period and in the next three months

Locations (2)

Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital

Thessaloniki, Greece

USVD "Centro per lo studio del glaucoma" Spedali civili di Brescia

Brescia, Italy

Outcomes

Primary Outcomes

Intraocular Pressure

Primary endpoint of this crossover trial is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.

Time frame: 24-hour