post-operative inflammation of eye anterior segment in the presence or at risk of bacterial infection MedDRA version: 6.1 Level: PT Classification code 10054765
Conditions
Interventions
Trade Name: BETABIOPTAL*0,2%+0,5%COLL5ML
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: BETAMETASONE DC.IT
CAS Number: 378-44-9
Concentration unit: mg milligram(s)
Concentration t
Sponsors
SIFI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects having to undergo phacoemulsification cataract extraction with intra-ocular lens implantation; 2. Able and willing to give informed consent; 3. Age 40; 4. Any race and sex; 5. Willing and able to attend required study visits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of ocular inflammatory diseases, ocular herpes infection, iritis, uveitis or Sjogren s syndrome; 2. Treatment for an external ocular infection within 1 month prior to study entry; 3. Concomitant ocular pathology including one of the following ocular infections, uveitis, iritis, iridocyclitis, glaucoma, proliferative diabetic retinopathy ; 4. Intraocular pressure 24 mmHg; 5. Ocular surgery in the affected eye within 12 months before the beginning of the study; 6. Laser treatment in the affected eye within 6 months before the beginning of the study; 7. Known or suspected allergy to ocular preservatives, phenylacetic acid derivatives, aminoglycosides and steroids; 8. Subjects currently participating in another clinical study or who have participated in a clinical study in the preceding 30 days; 9. Intake of any pharmaceutical form of antihistamines, decongestants, steroids or non-steroidal anti-inflammatory agents within 15 days prior to study entry 10. Use of ocular medication other than artificial tears; 11. Pregnant or nursing women or inadequate birth control methods applicable to female of childbearing potential only ; 12. Monophthalmic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare the efficacy of NETILDEX 0.3 netilmicin-0.1 dexamethasone ophthalmic solution with that of BETABIOPTAL 0.2 betamethasone-0.5 chloramphenicol ophthalmic suspension , in the control of post-surgical ocular inflammation following phacoemulsification cataract extraction;Secondary Objective: to assess the overall safety and the local tolerance of the investigational product;Primary end point(s): anterior chamber inflammation flare at visit 3 day 7 1 | — |
Countries
Italy
Outcome results
None listed