Comparison of 2 regimens of loteprednol etabonate and bromfenac for cataract surgery.

OBJECTIVE

We aimed to evaluate the safety and effectiveness of 2 dosing regimens of loteprednol etabonate (LE) ophthalmic gel 0.5% and bromfenac ophthalmic solution 0.07% in patients undergoing routine cataract surgery.

DESIGN

Six-week prospective, masked, randomized controlled noninferiority study.

PARTICIPANTS

One hundred eyes.

METHODS

Patients undergoing uncomplicated cataract surgery were selected in a consecutive manner. Patients were randomized to one of 2 groups: LE QID + qD bromfenac (control group) versus LE BID + qD bromfenac (study group). Primary outcome metrics included summed ocular inflammation score (SOIS) and adverse events. Secondary outcome measures included intraocular pressure, visual acuity, central retinal thickness, and subjective symptomology scores measured at 4 study visits. The final visit included a questionnaire addressing compliance, satisfaction, and comfort with the medications.

RESULTS

Both groups demonstrated similar effectiveness and safety between dosing regimens. No statistically significant difference was reported between groups regarding SOIS (visit 1 p = N/A, visit 2 p = 0.66, visit 3 p = 0.60, visit 4 p = 0.08). No adverse events were reported relating to the difference in study regimen. A statistically significant difference was not found regarding secondary outcomes (p > 0.05). Control group patients reported a more difficult time remembering their doses for bromfenac but not LE (bromfenac p < 0.05; LE p = 0.15).

CONCLUSIONS

Our data suggest that both groups had similar outcomes with respect to control of ocular inflammation with no differences in adverse outcomes. The compliance questionnaire also suggests a patient preference for the dosing regimen with lower frequency of drop application.