Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Brief summary
* 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
Interventions
DEVICEGoldmann and Perkins applanation tonometry
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
DRUGTAFLUPROST 0.0015% EYEDROPS
Tafluprost 0.0015% preservative-free ophthalmic solution
DRUGLATANOPROST 0.005% EYEDROPS
Latanoprost 0.005% preservative-added ophthalmic solution
Sponsors
Aristotle University Of Thessaloniki
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure | 24-hour | 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. |
Countries
Greece, Italy
Outcome results
None listed