For over 30 years, the Ora Conjunctival Allergen Challenge Model (Ora-CAC®) has been used to evaluate every anti-allergic agent for the treatment of allergic conjunctivitis. For the majority of these programs, Ora-CAC® Model studies were pivotal for FDA approval of the drug.
Allergy is a highly variable condition. While environmental studies continue to be used for the assessment of anti-allergic agents, the precision of the Ora-CAC® Model study design allows for a more predictive and rapid study, with fewer patients, fewer sites, and a tighter dataset.
The variable nature of allergen exposure and sensitivity, and the high placebo effect observed in ocular allergy studies are minimized by reproducing the allergic reaction in the office under controlled conditions.
The model incorporates validated severity scales to grade the signs and symptoms of ocular allergy. These scales have been accepted by regulatory agencies around the globe. The Ora-CAC® Model study design can be modified to better suit the MOA of your anti-allergic candidate – this is done routinely for studying the anti-inflammatory effects of novel agents in chronic allergy.
The Enviro-CAC™ Model – a best-of-both-worlds hybrid
To determine whether the candidate is effective in treating the signs and symptoms of ocular allergic inflammation following single and repeated conjunctival allergen challenges.
A Phase II Proof of Concept / dose ranging clinical study evaluating the efficacy and safety of a candidate in treating ocular surface inflammation, as induced by the Ora-CAC® model.
Regulatory quality data outcomes
Measures of safety, tolerability, and efficacy (clinical signs and symptoms, and inflammation as visualized by confocal microscopy) of different concentrations of IP compared to positive and negative controls.