glaucoma and ocular hypertension MedDRA version: 14.1 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: LUMIGAN*COLL FL 3ML 0,1MG/ML
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: BIMATOPROST
CAS Number: 155206-00-1
Current Sponsor code: NA
Other descriptive name: NA
Concentra
Sponsors
IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed informed consent • Age> 18 years • Diagnosis of glauocoma or ocular hypertension. The definition of glaucoma or ocular hypertension is based on the guidelines of the 'European Glaucoma Society • Patients newly diagnosed (Ocular hypertension and glaucoma) and never treated with ocular hypotensive drugs with any value tonometer and patients with OHT and POAG in ocular hypotensive drug therapy alone and with IOP =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Inability to sign informed consent • Ocular conditions that can interfere with the results of the study • Narrow angle or a history of acute attacks of glaucoma • eye infection or inflammation in the 3 months preceding the screening visit • eye surgery, or argon laser trabeculoplasty in the last three months. • History of hypersensitivity to benzalkonium chloride or other components contained in the formulation of study drug • Use of topical drugs that may interfere with the study medication • Causes of secondary increase of intraocular pressure • Contraindications to the use of systemic drugs in the studio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: evaluete: mean 24-hours IOP changes from baseline, IOP at each time point of the daily curve, mean day and night IOP, ocular hyperemia score, mean 24-hours systolic and diastolic blood pressure, mean 24-hours heart rate, incidence of adverse events, responses from questionnaire about drug tolerability and satisfaction;Primary end point(s): comparison between groups of the 24-hour mean IOP after 8 weeks of treatment;Timepoint(s) of evaluation of this end point: 5 months;Main Objective: to investigate the 24-hour IOP lowering efficacy and safety of Bimatoprost 0.01% administered once at night compared to Timolol 0.5% administered twice daily | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): mean 24-hours IOP changes from baseline, IOP at each time point of the daily curve, mean day and night IOP, ocular hyperemia score, mean 24-hours systolic and diastolic blood pressure, mean 24-hours heart rate, incidence of adverse events, responses from questionnaire about drug tolerability and satisfaction;Timepoint(s) of evaluation of this end point: 5 months | — |
Countries
Italy
Contacts
Public Contactunita' di ricerca glaucoma
IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA
Outcome results
None listed