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

Ocular Hypertension Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01162603
Study type Interventional
Source Azienda Ospedaliera Spedali Civili di Brescia
Contact
Status Completed
Phase Phase 4
Start date March 2011
Completion date April 2012
View Details
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