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

University of Catanzaro120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Intraocular Pressure (IOP)Tear Break-Up Time

Interventions

IOPIZE© Latanoprost eyedropsDRUG

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

GALAXIA© Latanoprost eyedropsDRUG

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© latanoprost eyedropsDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Catanzaro - Eye Department

Catanzaro, Catanzaro, Italy

RECRUITING

Outcomes

Primary Outcomes

intraocular pressure (IOP) in mmHg

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

Time frame: one month - two months

Secondary Outcomes

Tear Break-Up Time (BUT) expressed in seconds

After one and two months of therapy with latanoprost, tear BUT will be calculated, through the use of fluoresceine staining of the tear film.

Time frame: one month - two months

Central Contacts

Luigi Varano, M. D.

CONTACT

+3909613647365 luigi-varano@libero.it

Giovanni Scorcia, M. D.

CONTACT

+39 09613647135 scorcia@unicz.it

Data from ClinicalTrials.gov

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