NCT01162603

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Primary Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DEVICE	Goldmann 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
DRUG	TAFLUPROST 0.0015% EYEDROPS	Tafluprost 0.0015% preservative-free ophthalmic solution
DRUG	LATANOPROST 0.005% EYEDROPS	Latanoprost 0.005% preservative-added ophthalmic solution

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-07-14
• Last updated: 2013-05-07

Locations

2 sites across 2 countries: Greece, Italy