Abstract
Purpose::
To assess the efficacy and safety of difluprednate ophthalmic emulsion (DFBA) 0.05% in patients with endogenous anterior uveitis, in comparison with betamethasone (BM) 0.1% ophthalmic solution.
Methods::
136 patients were randomized to receive either one drop of DFBA 0.05% or one drop of BM 0.1%. Each drug was instilled 4 times daily for 14 days. Observation of symptoms and signs and IOP measurement were performed on Days 0, 3, 7 and 14. In addition, measurement of visual acuity and blood collection for laboratory tests were performed on Days 0 and 14. The primary endpoint was the change from the baseline in anterior chamber cell score on Day 14.
Results::
Improvement of anterior chamber cell score from baseline was comparable between both treatments at day 14, therefore verifying the non-inferiority hypothesis. DFBA was superior to BM on day 7 with regard to proportion of patients with cell score of 1+ or lower (P=0.0298) and total sign score (P=0.0355). Withdrawal from treatment due to symptom aggravation occurred in 3/67 patients on BM and 0/69 patients receiving DFBA. The incidence of increased IOP, a common side effect of corticosteroids, was equal between the two groups.
Conclusions::
Compared to BM, treatment with DFBA produced a significantly more rapid improvement in the clinical signs of anterior uveitis while maintaining a satisfactory safety profile. These data suggest a more potent and rapid anti-inflammatory effect of DFBA, which may provide better treatment for patients with anterior uveitis.
Clinical Trial::
www.clinicaltrials.gov NCT00406887
Keywords: corticosteroids • inflammation • anterior segment