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

Phase 4

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Device: Goldmann and Perkins applanation tonometry; Drug: TAFLUPROST 0.0015% EYEDROPS; Drug: LATANOPROST 0.005% EYEDROPS

• Registration Number: NCT01162603
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-13
• Study First Posted: 2010-07-14
• Study Start: 2011-03
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-05
• Last Update Posted: 2013-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TAFLUPROST 0.0015% EYEDROPS	TAFLUPROST 0.0015% EYEDROPS	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.
TAFLUPROST 0.0015% EYEDROPS	Goldmann and Perkins applanation tonometry	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.
LATANOPROST 0.005% EYEDROPS	Goldmann and Perkins applanation tonometry	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.
LATANOPROST 0.005% EYEDROPS	LATANOPROST 0.005% EYEDROPS	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

USVD "Centro per lo studio del glaucoma" Spedali civili di Brescia; 🇮🇹 Brescia, Italy

Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital; 🇬🇷 Thessaloniki, Greece