BACKGROUND: To compare the safety and efficacy of @entity3748 ophthalmic ointment 0.5% (LE ointment), a new topical ointment formulation, with vehicle for the treatment of @entity32 and @entity158 following @entity231 surgery. METHODS: Two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies were conducted. @entity1 aged >= 18 years with a combined postoperative anterior chamber cells and flare (ACI) >=  Grade 3 following uncomplicated @entity231 surgery participated in seven study visits. @entity1 self-administered either topical LE ointment or vehicle four times daily for 14 days. Efficacy outcomes included the proportion of @entity1 with complete resolution of ACI and the proportion of @entity1 with no (Grade 0) @entity158 at postoperative day 8. Safety outcomes included the incidence of adverse events, ocular symptoms, changes in intraocular pressure and visual acuity, and biomicroscopy and funduscopy findings. RESULTS: Data from the two studies were combined. The integrated intent-to-treat population consisted of 805 @entity1 (mean [standard deviation] age 69.0 [9.2] years; 58.0% female and 89.7% white). Significantly more LE ointment-treated @entity1 than vehicle-treated @entity1 had complete resolution of ACI (27.7% versus 12.5%) and no @entity158 (75.5% versus 43.1%) at day 8 (P < 0.0001 for both). Fewer LE ointment-treated @entity1 required rescue medication (27.7% versus 63.8%), and fewer had an ocular adverse event (47.2% versus 78.0%, P < 0.0001) while on study treatment. The most common ocular adverse events with LE ointment were @entity32 , photophobia, @entity3279 , @entity3169 , @entity3856 , and @entity5890 . Mean intraocular pressure decreased in both treatment groups. Four @entity1 had increased intraocular pressure >= 10 mmHg (three LE ointment and one vehicle) prior to rescue medication. Visual acuity and dilated funduscopy results were similar between the treatment groups, with the exception of visual acuity at visits 5 and 6, which favored LE ointment. CONCLUSION: LE ointment was efficacious and well tolerated in the treatment of @entity32 and @entity158 following @entity231 surgery.

Safety and efficacy of @entity3748 ophthalmic ointment 0.5% for the treatment of XXXX and @entity158 following @entity231 surgery.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity32 :: ('MESH:D007249', 'Disease') :: ['inflammation', 'ocular inflammation', 'anterior chamber inflammation'] @entity231 :: ('MESH:D002386', 'Disease') :: ['cataract'] @entity5890 :: ('MESH:D007500', 'Disease') :: ['iritis'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity3169 :: ('MESH:D003229', 'Disease') :: ['conjunctival hyperemia'] @entity3856 :: ('MESH:D058447', 'Disease') :: ['eye pain'] @entity3748 :: ('MESH:C063378', 'Chemical') :: ['loteprednol etabonate'] @entity3279 :: ('MESH:D015715', 'Disease') :: ['corneal edema']
@entity32 :: (MESH:D007249,Disease) :: ['inflammation']
