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

NCT ID: NCT01580254

Last Updated: 2012-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-07-31

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.

Conditions

Intraocular Pressure (IOP); Tear Break-Up Time

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IOPIZE© eyedrops

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

Group Type: ACTIVE_COMPARATOR

IOPIZE© Latanoprost eyedrops

Intervention Type: DRUG

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

GALAXIA© eyedrops

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

Group Type: ACTIVE_COMPARATOR

GALAXIA© Latanoprost eyedrops

Intervention Type: DRUG

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

Latanoprost RATIOPHARM© eyedrops

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

Group Type: ACTIVE_COMPARATOR

Latanoprost RATIOPHARM© latanoprost eyedrops

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

IOPIZE© eyedrops (S.I.F.I. S.p.A. - Aci S. Antonio (CT), Italy); authorization numbers: 039276011; 039276023; 039276035; GALAXIA© eyedrops (ALFA INTES Industria Terapeutica Splendore S.r.l. - Casoria (NA), Italy); authorization number: 038622015; Latanoprost RATIOPHARM© eyedrops (RATIOPHARM GmbH - Ulm, Germany); authorization number: 039468018/M

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Catanzaro

OTHER

Sponsor Role: lead

Responsible Party

Luigi Varano, MD - Principal Investigator

M. D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luigi Varano, M. D.

Role: PRINCIPAL_INVESTIGATOR

University of Catanzaro

Locations

University of Catanzaro - Eye Department

Catanzaro, Catanzaro, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Luigi Varano, M. D.

Role: CONTACT

luigi-varano@libero.it

+3909613647365

Giovanni Scorcia, M. D.

Role: CONTACT

scorcia@unicz.it

+39 09613647135

Facility Contacts

Luigi Varano, M.D.

Role: primary

luigi-varano@libero.it

+3909613647365

Giovanni Scorcia, M. D.

Role: backup

scorcia@unicz.it

+3909613647135

Other Identifiers

GENERIC-LATANOPROST

Identifier Type: -

Identifier Source: org_study_id