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

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cantanzaro; University of Catanzaro
• Treatments: Latanoprost; Ophthalmic Solutions; Tetrahydrozoline

Criteria

Inclusion Criteria:

• Age ranged between 18 and 80

• Untreated IOP ranged between 21 and 30 mmHg

• IOP already treated with a single drug (monotherapy) ranged between 10 and 28 mmHg

Exclusion Criteria:

• History of adverse events or any controindication to drugs administred during sperimentation, i. e. Latanoprost and Timolol.

• Narrow or closed iridocorneal angle.

• History of acute angle-closure glaucoma.

• Previous laser trabeculoplasty within 3 months before screening.

• Severe visual field defects within 10° from fixation in at least one eye (at least 2 points with a p<0,5 in a pattern deviation map obtained from a reliable 24-2 Sita Standard SAP).

• History of refractive surgery or any keratoplasty procedure, corneal opacities or diseases that make not suitable applanation tonometry.

• Use of contact lenses.

• BCVA less than 20/200.

• Ocular inflammation/infection occurring within three months before screening.

• History of bradicardia, systemic hypotension, bundle branch or any atrio-ventricular block

• Asthma

• Women of childbearing potential who were not using adequate contraceptive methods or who were pregnant or nursing