Allergic and Inflammatory Ocular Disorders
Loteprednol etabonate 0.2% ophthalmic suspension is used for the symptomatic relief of seasonal allergic (hay fever, pollinosis) conjunctivitis. Loteprednol etabonate 0.5% ophthalmic suspension also is used for the symptomatic relief of allergic conjunctivitis.
Avoidance of allergen and other triggering factors (e.g., irritants) and application of cold compresses and lubricating eye drops are the initial means of managing allergic conjunctivitis. Drug therapy generally is reserved for use when such avoidance is not possible or is ineffective, and can include both prophylactic (e.g., topical mast-cell stabilizers such as cromolyn sodium, lodoxamide tromethamine, olopatadine hydrochloride) and symptomatic (e.g., topical and/or systemic antihistamines, topical vasoconstrictors, topical steroidal and nonsteroidal anti-inflammatory agents [NSAIAs]) therapy. The specific therapy(ies) employed will depend on the characteristics and severity of the allergic conjunctivitis. For patients with seasonal allergic conjunctivitis, prophylaxis with a mast-cell stabilizer often is initiated before and maintained throughout the pollen season, and symptomatic therapy with other agents (e.g., topical antihistamines, topical NSAIAs) generally is initiated as necessary to provide acute relief. Topical corticosteroids usually are reserved for short-term use in patients with moderate to severe symptoms of allergic conjunctivitis. Regardless of the therapy employed (antihistamine, NSAIA, corticosteroid, vasoconstrictors), relief of all of the clinically important manifestations of allergic conjunctivitis may not be possible despite combined topical and/or systemic administration. In general, the least toxic therapy providing adequate relief should be employed.
Results from 2 double-blind, placebo-controlled clinical studies indicate that ophthalmic therapy with loteprednol etabonate 0.2% is more effective than vehicle in providing symptomatic relief of seasonal allergic conjunctivitis. In these studies, improvement in ocular manifestations (e.g., ocular itching, bulbar conjunctival injection) occurred within 2 hours following initiation of therapy and persisted through day 14 of therapy. At day 14, complete resolution of symptoms of bulbar conjunctival injection occurred in 31-36 or 9-15% of patients receiving loteprednol etabonate or vehicle, respectively, while resolution of itching was reported in 54-58 or 38% of these patients, respectively.
Loteprednol etabonate 0.5% ophthalmic suspension is used for the symptomatic relief of corticosteroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea keratitis, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis.
Results from one randomized, double-blind, placebo-controlled study indicate that short-term ophthalmic therapy (6 weeks) with loteprednol etabonate 0.5% initiated before the period of peak pollen exposure, is more effective than vehicle in providing symptomatic relief of seasonal allergic conjunctivitis (e.g., ocular itching, bulbar conjunctival injection). In this study, 94 or 78% of patients receiving loteprednol etabonate 0.5% or vehicle, respectively, were asymptomatic (i.e., with scores of mild or none for itching and bulbar injection) during the 3-week peak pollen season. In addition, 77 or 68% of patients receiving the 0.5% suspension or vehicle, respectively, were asymptomatic (i.e., with scores of mild or none for discomfort, tearing, and chemosis), while 86 or 64% of patients receiving the drug or vehicle, respectively, were considered asymptomatic according to the investigator global assessment (e.g., conjunctival injection, tearing, erythema, chemosis, foreign body sensation).
In controlled studies in patients with contact lens-associated giant papillary conjunctivitis, ophthalmic therapy with loteprednol etabonate 0.5% for 4-6 weeks was associated with greater improvement in papillae, conjunctival injection and itching, and lens intolerance than administration of vehicle. In these studies efficacy of loteprednol etabonate was evident within 1 week of initiation of therapy and persisted for up to 6 weeks while therapy was continued; patients generally resumed contact lens wear within 2-3 days after starting therapy.
Loteprednol etabonate 0.5% ophthalmic suspension also is used in the treatment of anterior uveitis. Results from controlled clinical studies in patients with acute anterior uveitis indicate that loteprednol etabonate 0.5% is less effective than prednisolone acetate 1% in the management of anterior uveitis as determined by reductions from baseline in anterior chamber cells and flare. At day 28, 87 or 72% of patients receiving prednisolone or loteprednol etabonate, respectively, experienced resolution of anterior chamber cells.
Postoperative Ocular Inflammation
In ophthalmology, topical loteprednol etabonate 0.5% suspension is used after ocular surgery for the treatment of postoperative ocular inflammation. In controlled studies, topical application to the eye of loteprednol etabonate 0.5% suspension was more effective than vehicle in the management of postoperative anterior chamber inflammation as determined by slit-lamp biomicroscopic evaluation of the number of anterior chamber cells and severity of anterior chamber flare.
Bacterial Ophthalmic Infections
Loteprednol etabonate is used topically in conjunction with topical tobramycin in some cases of bacterial ocular infections. Concomitant therapy with loteprednol etabonate and tobramycin may be used for steroid-responsive ocular inflammatory conditions for which a corticosteroid is indicated and where a superficial ocular bacterial infection or risk of ocular bacterial infection exists.