Efficacy and safety of topical steroid/antibiotic association treatments following phacoemulsification cataract extraction - ND

• Conditions: post-operative inflammation of eye anterior segment in the presence or at risk of bacterial infection; MedDRA version: 6.1Level: PTClassification code 10054765

• Registration Number: EUCTR2006-003305-13-IT
• Lead Sponsor: SIFI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified