Drug-associated corneal hypoaesthesia and neurotrophic keratopathy: a disproportionality analysis of FAERS/AEMS

This document is the prespecified analysis protocol for a disproportionality analysis of drug-associated corneal hypoaesthesia and neurotrophic keratopathy using the FDA Adverse Event Reporting System (FAERS/AEMS), covering 47 consecutive quarters from 2014Q3 to 2026Q2 (15,955,446 unique reports). It was written on 3 November 2026, after the dataset was assembled and after inspection of event-term frequencies, but before any disproportionality measure was computed. No ROR, PRR, IC or EBGM value had been calculated at the time of writing. What was known when the protocol was fixed is declared explicitly in the document: the total number of unique reports, the frequency of each MedDRA Preferred Term matching a deliberately broad text filter, and a raw count of reports per drug name mentioning any ocular term, inspected to confirm that the extraction pipeline was functioning. This is partial knowledge of the data, not of the result. The protocol specifies the case definition and the terms deliberately excluded, the exposure definition and drug-name harmonisation rules, a prespecified exclusion list for confounding by indication, the deduplication strategy, the four signal-detection measures and their thresholds, positive and negative controls, six sensitivity analyses, anticipated biases, and stopping and reframing rules fixed in advance. It is deposited so that the analysis plan can be verified as predating the results. Reporting will follow READUS-PV.