Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Intervention: Levofloxacin + Dexamethasone; Levofloxacin; Dexamethasone
Intervention description: Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis.; Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).; Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.
Intervention MeSH terms: Levofloxacin; Ofloxacin; Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, assessor-blinded, parallel-group study.
Masking: Single (Outcomes Assessor)
Masking description: Single
Enrollment: 125.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the penetration of levofloxacin and dexamethasone
      21-phosphate into the aqueous humour after ocular administration in combination or as single
      active ingredients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent

          2. Male or female patients, aged ≥40 years

          3. Patient undergoing phacoemulsification

          4. Corneal thickness between 450 μm and 600 μm as measured by means of pachymetry

          5. Corneal integrity confirmed by means of fluorescein test

          6. Adequate pupil dilation assessed at screening

          7. Female patients of childbearing potential must have a negative pregnancy test

          8. Ability to fully understand all study procedures

        Exclusion Criteria:

          1. Corneal epithelium integrity not confirmed by fluorescein test

          2. History of corneal disease or dystrophy

          3. History of ocular trauma with corneal damage

          4. History of acute ocular inflammation (including uveitis) in the 6 months prior to
             screening

          5. Previous ocular surgery (including laser treatment)

          6. Glaucoma

          7. Treatment with an ophthalmic investigational drug in the 3 months prior to screening

          8. Treatment with any topical ocular drug within 12 hours before start of cataract
             surgery other than study drugs and instillation of topical anaesthetic within 10
             minutes before start of surgery

          9. Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract
             surgery

         10. Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract
             surgery

         11. Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone

         12. Pregnant or lactating women

         13. Patients who have received any investigational drug during the preceding 30 days or 5
             times the plasma half-life, or who have previously participated in this trial