Abstract
Purpose :
The hallmark sign of blepharitis is lid margin redness. A standardized redness grading scale is critical for the evaluation of drug efficacy. We established the standardized conjunctival redness scale over 25 years ago and it has found widespread usage in clinical trials and the drug approval process.
Methods :
The process used in the creation of lid margin redness scale is similar to the method used to create the conjunctival redness sale. We reviewed 74 photos from patients with lid margin redness associated with various levels of severity of blepharitis. Photos were then organized mild to most severe by a group of clinical researchers. A 0-3 scale was selected as it represents a 25% gradation between scores. For each of these scores, the best photo representation with descriptors along the continuum was selected. The combination of verbal descriptors and clear photograph examples is important in providing the clinical grader appropriate guidance. Clinicians not involved in this process used this scale in a pilot single center study and in 3 multi-center trials where it was successfully validated.
Results :
The scale was very sensitive and detected efficacy of an antibiotic/steroid combination with reduction from baseline in lid margin redness of 0.50 units, P=0.0007.
Conclusions :
We have repeated a successful methodology to create a standardized scale for the endpoint of lid margin redness associated with blepharitis.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.