NCT01580254

Efficacy and Safety of Three Different Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma

Phase 4 Study to Evaluate Efficacy And Safety of Three Different Preparations of Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Catanzaro · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study examines efficacy and tolerability of 3 different Latanoprost 0.005% eyedrops preparations, commercially available in Italy, in subjects affected by primary open angle glaucoma.

Detailed description

Prospective, randomized, single blinded study of the duration of 3 months, involving subjects affected by POAG or OH under therapy with different Latanoprost drugs (Galaxia, Iopize or Latanoprost Rathiopharm). A total of 120 patients affected by POAG or OH newly diagnosed or already under topical therapy. will be recruited. After a recruitment visit to assest eligibility of each subject, a "run-in" therapy composed of timolol 0,5% 2 drops per day will be prescribed for 4 weeks. Then a baseline visit will be performed to evaluate IOP values and adverse effects in each subject. All subjects elegible for a therapy with a single dose of Latanoprost will be randomized into 3 arms. After 4 weeks of therapy a second visit will be made to assest IOP changes and safety. Therapy will be continued for another 4 weeks, and after that, a final visit will be made.

Conditions

• Intraocular Pressure (IOP)
• Tear Break-Up Time

Interventions

Type	Name	Description
DRUG	IOPIZE© Latanoprost eyedrops	patients will receive in each eligible eye one drop of IOPIZE© Latanoprost eyedrops once a day, in the evening (8pm), for two months
DRUG	GALAXIA© Latanoprost eyedrops	patients will receive in each eligible eye one drop of GALAXIA© Latanoprost eyedrops once a day, in the evening (8pm), for two months
DRUG	Latanoprost RATIOPHARM© latanoprost eyedrops	patients will receive in each eligible eye one drop of Latanoprost RATIOPHARM© Latanoprost eyedrops once a day, in the evening (8pm), for two months

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2012-04-18
• Last updated: 2012-04-18

Locations

1 site across 1 country: Italy