Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
Condition: Cataract
MeSH terms: Cataract; Inflammation
Intervention: Levofloxacin + dexamethasone followed by dexamethasone; Tobramycin + Dexamethasone
Intervention description: Levofloxacin + dexamethasone ophthalmic solution for 7 days, 1 drop - 4 times a day, followed by dexamethasone ophthalmic suspension (Maxidex®) for an additional 7 days, 1 drop - 4 times a day.; Tobramycin + dexamethasone ophthalmic suspension (Tobradex®) for 14 days, 1 drop - 4 times a day.
Intervention MeSH terms: Levofloxacin; Ofloxacin; Tobramycin; Tobramycin, Dexamethasone Drug Combination; Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, parallel-group study
Masking: Single (Outcomes Assessor)
Enrollment: 808.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate the non-inferiority of the study treatment
      (combined levofloxacin + dexamethasone eye drops) followed by dexamethasone eye drops alone
      vs. standard treatment in the prevention and treatment of postoperative ocular inflammation
      and prevention of infection.
    

Eligibility criteria:

        Inclusion Criteria prior to surgery:

          1. Signed written informed consent

          2. Male or female, age ≥40 years

          3. Scheduled senile or presenile cataract surgery

          4. Willing to interrupt the use of contact lenses for the entire duration of the study

          5. Able and willing to follow study procedures

          6. Female patients must be postmenopausal, surgically sterile or must agree to use an
             effective method of contraception

             Inclusion criteria following surgery:

          7. Surgery completed without complications

        Exclusion Criteria:

          1. Ocular conditions that at the discretion of the Investigator may interfere with the
             efficacy and/or safety evaluations

          2. Patients undergoing bilateral cataract surgery

          3. Patients under treatment with prostaglandin analogues or intravitreal injections of
             anti-vascular endothelial growth factor (VEGF) drugs

          4. Systemic diseases that may interfere with the results of the study

          5. Any condition that could interfere with correct instillation of eye drops

          6. Ocular surgery in the study eye (including laser surgery) in the 3 months before
             screening

          7. Monocular patients

          8. Visual Acuity < 20/80 of the contralateral eye measured as ETDRS or Snellen

          9. Contraindications to ocular treatment with Tobradex®, Maxidex® or
             levofloxacin/dexamethasone

         10. Hypersensitivity to the study product or its excipients

         11. Participation in other clinical studies within at least 5 half-lives of the
             Investigational Medicinal Product (IMP) used in the previous studies

         12. Pregnancy or breastfeeding