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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOPIZE© eyedrops | Active Comparator | subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE© |
|
| GALAXIA© eyedrops | Active Comparator | subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA© |
|
| Latanoprost RATIOPHARM© eyedrops | Active Comparator | subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM© |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Varano, M. D. | Contact | +3909613647365 | luigi-varano@libero.it | |
| Giovanni Scorcia, M. D. | Contact | +39 09613647135 | scorcia@unicz.it |
| Name | Affiliation | Role |
|---|---|---|
| Luigi Varano, M. D. | University of Catanzaro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Catanzaro - Eye Department | Recruiting | Catanzaro | Catanzaro | 88100 | Italy |
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|
| 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 |
|
|
| 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 |
|
|
| ID | Term |
|---|---|
| D012964 | Sodium |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
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