Efficacy and Safety of Three Different Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma (LATANOPROST)
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|ClinicalTrials.gov Identifier: NCT01580254|
Recruitment Status : Unknown
Verified April 2012 by Luigi Varano, MD - Principal Investigator, University of Catanzaro.
Recruitment status was: Recruiting
First Posted : April 18, 2012
Last Update Posted : April 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Intraocular Pressure (IOP) Tear Break-Up Time||Drug: IOPIZE© Latanoprost eyedrops Drug: GALAXIA© Latanoprost eyedrops Drug: Latanoprost RATIOPHARM© latanoprost eyedrops||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||July 2012|
Active Comparator: IOPIZE© eyedrops
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE©
Drug: 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
Active Comparator: GALAXIA© eyedrops
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA©
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
Active Comparator: Latanoprost RATIOPHARM© eyedrops
subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM©
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
- intraocular pressure (IOP) in mmHg [ Time Frame: one month - two months ]to evaluate intraocular pressure (IOP) reduction after one and two months treatment with latanoprost eyedrops
- Tear Break-Up Time (BUT) expressed in seconds [ Time Frame: one month - two months ]After one and two months of therapy with latanoprost, tear BUT will be calculated, through the use of fluoresceine staining of the tear film.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580254
|Contact: Luigi Varano, M. D.||+firstname.lastname@example.org|
|Contact: Giovanni Scorcia, M. D.||+39 email@example.com|
|University of Catanzaro - Eye Department||Recruiting|
|Catanzaro, Italy, 88100|
|Contact: Luigi Varano, M.D. +3909613647365 firstname.lastname@example.org|
|Contact: Giovanni Scorcia, M. D. +3909613647135 email@example.com|
|Principal Investigator: Luigi Varano, M. D.|
|Sub-Investigator: Valentina De Luca|
|Principal Investigator:||Luigi Varano, M. D.||University of Catanzaro|