In vitro ocular testing was performed by Stillmeadow, Inc. using the commercially available EpiOcularTM model.
In vivo ocular testing was performed by Stillmeadow, Inc. according to U.S. Environmental Protection Agency guidelines (OPPTS 870.2400) [ 8].
Specific and adapted ophthalmological electronic medical record software can provide real-time data including all ocular tests and ophthalmological investigations [ 5].
KM served as the study coordinator for Stillmeadow, Inc., where the EpiOcularTM assay and the in vivo ocular testing were carried out.
The sensitivity and specificity for several other ocular tests used by non-ophthalmic health personnel including the red reflex, confrontation visual fields, and penlight test for photophobia to detect "serious" pathology has been measured with various results [ 9- 13].
According to the AECG criteria, a complete work up for pSS was performed in all the patients and controls, including a standardized clinical examination performed by the same rheumatologist, serological and laboratory tests, ocular tests, assessment of the unstimulated salivary flow rate (USFR) and MSGB.
Although precise numbers are not available for the use of live animals in ocular testing, William Stokes, director of NICEATM and executive director of ICCVAM, estimates that based on the relative distribution of adverse effects, use of the two assays could reduce the use of live animals for eye safety testing by 10% or more.
An ocular examination including visual testing by the menace response and pupillary light reflexes, as well as indirect and direct ophthalmoscopy after pupil dilation with topical 0.5% tropicamide was performed.
Additional exclusion criteria included clinically significant abnormalities on ocular-motor and vestibulo-ocular testing, which was performed on a separate visit prior to randomization.
Vestibulo-ocular testing based on oculo-cephalic movement requires an intact cervical spine and an intact cervico-occipital junction [ 32].
