Intraocular Pressure (IOP) Clinical Trial
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
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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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment