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

Study Overview
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Brief Summary
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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

Official Title
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Comparative Evaluation of Intraocular Pressure During the 24 Hour in Patients Affected by Primary Open-angle Glaucoma and Ocular Hypertension: Latanoprost 0.005% Versus Tafluprost 0.0015% Ophthalmic Solutions

Conditions
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Ocular Hypertension, Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: Goldmann and Perkins applanation tonometry
* Drug: TAFLUPROST 0.0015% EYEDROPS
* Drug: LATANOPROST 0.005% EYEDROPS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAFLUPROST 0.0015% EYEDROPS<br>Tafluprost 0.0015% preservative-free ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means of Goldmann and Perkins applanation tonometry. | Device: Goldmann and Perkins applanation tonometry<br>* 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<br>* Other names: Latanoprost 0.005% generic drug;Drug: TAFLUPROST 0.0015% EYEDROPS<br>* Tafluprost 0.0015% preservative-free ophthalmic solution<br>* Other names: Saflutan, MSD;|
| Active Comparator: LATANOPROST 0.005% EYEDROPS<br>Latanoprost 0.005% preservative-added ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means Goldmann and Perkins applanation tonometry. | Device: Goldmann and Perkins applanation tonometry<br>* 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<br>* Other names: Latanoprost 0.005% generic drug;Drug: LATANOPROST 0.005% EYEDROPS<br>* Latanoprost 0.005% preservative-added ophthalmic solution<br>* Other names: Latanoprost 0.005% eyedrops generic drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24-hour |