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

NCT01580254 | Unknown Phase 4

• 1 other identifier: GENERIC-LATANOPROST
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Pressure (IOP); Tear Break-Up Time

Keywords

Latanoprost; IOP

Outcome Measures

Primary Outcomes (1)

• intraocular pressure (IOP) in mmHg

  to evaluate intraocular pressure (IOP) reduction after one and two months treatment with latanoprost eyedrops

  one month - two months

Secondary Outcomes (1)

• Tear Break-Up Time (BUT) expressed in seconds

  one month - two months

Study Arms (3)

IOPIZE© eyedrops

ACTIVE COMPARATOR

subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE©

Drug: IOPIZE© Latanoprost eyedrops

GALAXIA© eyedrops

ACTIVE COMPARATOR

subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA©

Drug: GALAXIA© Latanoprost eyedrops

Latanoprost RATIOPHARM© eyedrops

ACTIVE COMPARATOR

subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM©

Drug: Latanoprost RATIOPHARM© latanoprost eyedrops

Interventions

IOPIZE© Latanoprost eyedrops DRUG

patients will receive in each eligible eye one drop of IOPIZE© Latanoprost eyedrops once a day, in the evening (8pm), for two months

Also known as: IOPIZE© eyedrops (S.I.F.I. S.p.A. - Aci S. Antonio (CT), Italy), authorization numbers:, 039276011, 039276023, 039276035

IOPIZE© eyedrops

GALAXIA© Latanoprost eyedrops DRUG

patients will receive in each eligible eye one drop of GALAXIA© Latanoprost eyedrops once a day, in the evening (8pm), for two months

Also known as: GALAXIA© eyedrops (ALFA INTES Industria Terapeutica Splendore S.r.l. - Casoria (NA), Italy), authorization number:, 038622015

GALAXIA© eyedrops

Latanoprost RATIOPHARM© latanoprost eyedrops DRUG

patients will receive in each eligible eye one drop of Latanoprost RATIOPHARM© Latanoprost eyedrops once a day, in the evening (8pm), for two months

Also known as: Latanoprost RATIOPHARM© eyedrops (RATIOPHARM GmbH - Ulm, Germany), authorization number:, 039468018/M

Latanoprost RATIOPHARM© eyedrops

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

University of Catanzaro - Eye Department

Catanzaro, Catanzaro, 88100, Italy

RECRUITING

MeSH Terms

Interventions

Sodium

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Luigi Varano, M. D.

  University of Catanzaro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Varano, M. D.

CONTACT

+3909613647365; luigi-varano@libero.it

Giovanni Scorcia, M. D.

CONTACT

+39 09613647135; scorcia@unicz.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M. D.

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 18, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 18, 2012

Record last verified: 2012-04

Locations

IT (1)