Intraocular Pressure (IOP), Tear Break-Up Time
Conditions
Keywords
Latanoprost, IOP
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.
Interventions
DRUGIOPIZE© 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
DRUGGALAXIA© 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
DRUGLatanoprost 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
Sponsors
University of Catanzaro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactLuigi Varano, M. D.
Backup ContactGiovanni Scorcia, M. D.
Outcome results
None listed