The Conjunctival Allergen Challenge (Ora-CAC®)
Highly trained clinicians are present during the procedure to monitor subjects' allergic reactions using objective assessments
Subject Sensitivity Matching
The model reproduces the signs and symptoms of allergic conjunctivitis in a controlled fashion that yields precise, reproducible results
Subject Allergen Matching
The model screens for new compounds, identify optimum concentrations, and accurately measure both drug efficacy and duration of action
Ora-CAC® Clinical Trial Results
19 of the current ocular allergy prescriptions on the market today have been approved by the FDA based on programs conducted by Ora using Ora's models
Over the past three decades, the Ora Conjunctival Allergen Challenge (Ora-CAC®) Model System has been used to evaluate every anti-allergic agent available today for the treatment of allergic conjunctivitis, and for the majority of these, Ora-CAC® model studies were pivotal for FDA approval of the drug.
The Ora-CAC® was developed to create a controlled setting in which to evaluate anti-allergic agents using both objective and subjective measurements. The Ora-CAC® model accurately reproduces the signs and symptoms of Seasonal Allergic Conjunctivitis by replicating the natural disease process. It is highly reproducible due to its controlled, standardized design and objective evaluation of a drug’s efficacy.
Ora has established a comprehensive protocol of specific procedures to ensure the consistently successful execution of the Ora-CAC® model:
- Precise standardization
- Proper investigator training
- Large database of qualified subjects
- Proven recruiting methodology
- Block enrollment of subjects
- Advanced assessment techniques
- Selection of proper timepoints
- Safety system that allows for the maximum safe level of titration to show therapeutic effect
The Ora-CAC® model of allergic conjunctivitis is the ideal method for testing the activity and duration of anti allergic pharmacological agents. It elicits the signs and symptoms of the disease in a physiologically accurate and reproducible manner. The rigid criteria for subject selection, the controlled allergic reaction, and the standardized and quantified grading systems allow for a reproducible baseline from which statistically and clinically significant differences between active and control (or two active formulations) can be tested.