Efficacy and Safety of Three Different Latanoprost 0,005% Eyedrops in Subjects Affected by Primary Open Angle Glaucoma
- Conditions
- Intraocular Pressure (IOP)Tear Break-Up Time
- Interventions
- Drug: IOPIZE© Latanoprost eyedropsDrug: GALAXIA© Latanoprost eyedrops
- Registration Number
- NCT01580254
- Lead Sponsor
- University of Catanzaro
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IOPIZE© eyedrops IOPIZE© Latanoprost eyedrops subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is IOPIZE© GALAXIA© eyedrops GALAXIA© Latanoprost eyedrops subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is GALAXIA© Latanoprost RATIOPHARM© eyedrops Latanoprost RATIOPHARM© latanoprost eyedrops subjects will receive a IOP-lowering therapy with latanoprost eyedrops. Drug commercial name is Latanoprost RATIOPHARM©
- Primary Outcome Measures
Name Time Method intraocular pressure (IOP) in mmHg one month - two months to evaluate intraocular pressure (IOP) reduction after one and two months treatment with latanoprost eyedrops
- Secondary Outcome Measures
Name Time Method Tear Break-Up Time (BUT) expressed in seconds 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.
Trial Locations
- Locations (1)
University of Catanzaro - Eye Department
🇮🇹Catanzaro, Italy