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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 4 Study to Evaluate Efficacy And Safety of Three Different Preparations of Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma

Conditions
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Intraocular Pressure (IOP), Tear Break-Up Time

Intervention / Treatment
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* Drug: IOPIZE© Latanoprost eyedrops
* Drug: GALAXIA© Latanoprost eyedrops
* Drug: Latanoprost RATIOPHARM© latanoprost eyedrops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IOPIZE© eyedrops<br>subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE© | Drug: IOPIZE© Latanoprost eyedrops<br>* patients will receive in each eligible eye one drop of IOPIZE© Latanoprost eyedrops once a day, in the evening (8pm), for two months<br>* Other names: 039276035;|
| Active Comparator: GALAXIA© eyedrops<br>subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA© | Drug: GALAXIA© Latanoprost eyedrops<br>* patients will receive in each eligible eye one drop of GALAXIA© Latanoprost eyedrops once a day, in the evening (8pm), for two months<br>* Other names: 038622015;|
| Active Comparator: Latanoprost RATIOPHARM© eyedrops<br>subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM© | Drug: Latanoprost RATIOPHARM© latanoprost eyedrops<br>* patients will receive in each eligible eye one drop of Latanoprost RATIOPHARM© Latanoprost eyedrops once a day, in the evening (8pm), for two months<br>* Other names: 039468018/M;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one month - two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Latanoprost, IOP