Abstract
Purpose :
Bromfenac ophthalmic solutions (0.07%-0.1%) with various dosing regimens have been approved to address ocular inflammation and pain in patients undergoing cataract surgery. We performed a randomized, double masked, multicenter, parallel-group study to compare the ocular safety, tolerability and efficacy of once daily (QD) versus twice daily (BID) dosing regimens of 0.075% bromfenac ophthalmic solution formulated in DuraSite for the treatment of ocular inflammation and pain post cataract surgery.
Methods :
Subjects received: 0.075% bromfenac QD (n=45), 0.075% bromfenac BID (n=40), or DuraSite Vehicle BID (n=42) for 14 days post surgery (Day 0). Subjects were assessed on Days 1 and 8 during the 14-day dosing period and on Days 15 and 29 during the post-treatment evaluation phase. The primary efficacy endpoint was the proportion of patients with anterior chamber cell grade of 0 at Day 15. Pain/discomfort and photophobia were evaluated using a visual analogue scale (VAS) at each visit, including a telephone call on Day 3. Intraocular pressure (IOP) and best corrected visual acuity (BCVA) were measured in both eyes at all visits. An ophthalmoscopy examination was conducted in both eyes on Days 1 and 29.
Results :
A statistically higher proportion of subjects in 0.075% bromfenac QD (p=0.0016) and 0.075% bromfenac BID (p=0.0024) groups had cleared anterior chamber cells at Day 15 compared to the Vehicle BID group (53.3% vs. 19.0% and 52.5% vs. 19.0%, respectively). In general, both 0.075% bromfenac groups showed significantly superior results for most slit-lamp biomicroscopy results compared to the Vehicle BID group. Combined 0.075% bromfenac QD and 0.075% bromfenac BID groups had significantly less pain or discomfort, and photophobia than the Vehicle BID group. The incidence of adverse events was comparable between all groups and no major differences were observed in BCVA, IOP, biomicroscopy, or ophthalmoscopy evaluations.
Conclusions :
When choosing a dosing regimen, 0.075% bromfenac dosed QD and BID appear to be equally safe and efficacious in treating inflammation and pain post cataract surgery. Although a QD regimen provides convenience for the patient, based on pharmacokinetic properties of bromfenac a QD regimen could result in sub-therapeutic drug levels in the eye for an extended period if a patient misses just one dose.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.