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

Phase 4

• Conditions: Intraocular Pressure (IOP); Tear Break-Up Time
• Interventions: Drug: IOPIZE© Latanoprost eyedrops; Drug: GALAXIA© Latanoprost eyedrops; Drug: Latanoprost RATIOPHARM© latanoprost eyedrops

• Registration Number: NCT01580254
• Lead Sponsor: University of Catanzaro

Brief 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.

Study Timeline

• Study Start: 2011-06
• Status Verified: 2012-04
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-17
• Last Update Submitted: 2012-04-17
• Study First Posted: 2012-04-18
• Last Update Posted: 2012-04-18
• Primary Completion: 2012-06
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IOPIZE© eyedrops	IOPIZE© Latanoprost eyedrops	subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE©
GALAXIA© eyedrops	GALAXIA© Latanoprost eyedrops	subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA©
Latanoprost RATIOPHARM© eyedrops	Latanoprost RATIOPHARM© latanoprost eyedrops	subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM©

Primary Outcome Measures

Name	Time	Method
intraocular pressure (IOP) in mmHg	one month - two months	to evaluate intraocular pressure (IOP) reduction after one and two months treatment with latanoprost eyedrops

Secondary Outcome Measures

Name	Time	Method
Tear Break-Up Time (BUT) expressed in seconds	one month - two months	After one and two months of therapy with latanoprost, tear BUT will be calculated, through the use of fluoresceine staining of the tear film.

Trial Locations

Locations (1)

University of Catanzaro - Eye Department; 🇮🇹 Catanzaro, Italy