Levofloxacin / Dexamethason (1) – Ducressa®

Adults for the prevention and treatment of inflammation and for the prevention of infections associated with cataract surgery

• Additional benefit is not proven
• There is no evidence of additional benefit for the combination of levofloxacin and dexamethasone in adults for the prevention and treatment of inflammation and for the prevention of infections associated with cataract surgery, compared with the appropriate comparator therapy, tobramycin andThere is no proof that dexamethasone is effective.
• mortality
  • No statistically significant difference was observed between the treatment arms for the endpoint of overall mortality.
• Morbidity – endophthalmitis
  • The endpoint of endophthalmitis was recorded on days 4, 8 and 15 of the study.
  • No cases of endophthalmitis occurred during the study.
• Morbidity – itching/burning, conjunctival redness, tearing and ocular pain/discomfort (each assessed as absence of symptoms)
  • For the endpoints of itching/burning, conjunctival redness, tearing and ocular pain/discomfort (each considered as freedom from symptoms), no statistically significant differences were observed between the treatment arms at any assessment time point.
• Morbidity – Decrease in visual acuity
  • For the endpoint of reduced visual acuity, assessed using the Snellen or Early Treatment of Diabetic Retinopathy Study (ETDRS) chart in accordance with local clinical practice, no statistically significant difference was observed between the treatment arms.
• Health-related quality of life
  • No endpoints relating to health-related quality of life were assessed in the LEADER-7 study.
• Side effects – severe adverse events (SUEs) and discontinuation due to adverse events (UEs)
  • For the endpoints SUE and discontinuation due to AEs, no statistically significant differences were observed between the treatment arms.
• Overall assessment / Conclusion
  • For adults, regarding the prevention and treatment of inflammation and the prevention of infections associated with cataract surgery, results are available from the head-to-head LEADER-7 trial comparing levofloxacin/dexamethasone with tobramycin/dexamethasone.
  • In summary, there were no statistically significant differences between the treatment arms in the results for mortality or morbidity.
  • No endpoints were assessed in the category of health-related quality of life.
  • In the category of side effects, no overall advantages or disadvantages can be identified for levofloxacin/dexamethasone compared with tobramycin/dexamethasone.
  • Consequently, there is no evidence of additional benefit for the combination of levofloxacin and dexamethasone in adults for the prevention and treatment of inflammation, as well as for the prevention of infections associated with cataract surgery, compared with the appropriate comparator therapy, tobramycin andThere is no proof that dexamethasone is effective.

Courtesy translation only, please refer to the German original.