NCT01162603: SAF-24H-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

Completed Phase 4 Last updated 5 May 2013

What this trial tests

Phase 4 trial testing Goldmann and Perkins applanation tonometry in Primary Open Angle Glaucoma in 40 participants. Completed in 1 April 2012.

Timeline

1 March 2011

Primary endpoint
1 April 2012

1 April 2012

Quick facts

Lead sponsor	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 March 2011
Primary completion	1 April 2012
Estimated completion	1 April 2012
Sites	2 locations across Greece, Italy

Drugs / interventions tested

• Goldmann and Perkins applanation tonometry
• TAFLUPROST 0.0015% EYEDROPS — full drug profile →
• LATANOPROST 0.005% EYEDROPS — full drug profile →

Conditions studied

• Primary Open Angle Glaucoma — all drugs for Primary Open Angle Glaucoma →
• Ocular Hypertension — all drugs for Ocular Hypertension →

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — full company profile →

Who can join

45 and older, any sex, with Primary Open Angle Glaucoma or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Intraocular Pressure
  Time frame: 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 va

Sponsor's own description

* 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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Twenty-four hour efficacy with preservative free tafluprost compared with latanoprost in patients with primary open angle glaucoma or ocular hypertension.
   Konstas AG, Quaranta L, Katsanos A, Riva I, et al · · 2013 · cited 47× · PMID 23681371 · DOI 10.1136/bjophthalmol-2012-303026