vehicle gel

The vehicle gel is the pharmacologically inactive formulation used as a placebo control in clinical trials conducted by Bausch & Lomb, specifically for the evaluation of Lotemax SM (loteprednol etabonate ophthalmic gel, 0.38%). It is designed to be physically and visually identical to the active drug product, utilizing the same submicron-sized gel matrix technology but without the active corticosteroid ingredient. The formulation includes moisturizing excipients such as glycerin and propylene glycol and is preserved with a low concentration of benzalkonium chloride (0.003%). In Phase 3 studies for postoperative ocular inflammation and pain following cataract surgery, the vehicle gel serves as the comparator to establish the therapeutic efficacy and safety profile of the active loteprednol etabonate formulation.

Other names

Vehicle Gel (BID)