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

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status and phase: Completed; Phase 4

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Treatments: Drug: TAFLUPROST 0.0015% EYEDROPS; Device: Goldmann and Perkins applanation tonometry; Drug: LATANOPROST 0.005% EYEDROPS

Study type: Interventional

Funder types: Other

Identifiers

NCT01162603

AOBS-SAF-01

Details and patient eligibility

About

• 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

Enrollment: 40 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

TAFLUPROST 0.0015% EYEDROPS

Experimental group

Description:

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.

Treatment:

Drug: TAFLUPROST 0.0015% EYEDROPS

Device: Goldmann and Perkins applanation tonometry

LATANOPROST 0.005% EYEDROPS

Active Comparator group

Description:

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.

Treatment:

Drug: LATANOPROST 0.005% EYEDROPS

Device: Goldmann and Perkins applanation tonometry