A Mixed Model, Repeated Measure Analysis of Demographics and Dry Eye Signs and Symptoms in a Dry Eye Population
Tempe, AZ, May 1, 2015 – Kirk Bateman, Director of Biostatistics at SDC, will be presenting a poster at the Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting in Denver, CO on Wednesday, May 6.
Kirk is first author on the research presented in “A Mixed Model, Repeated Measure Analysis of Demographics and Dry Eye Signs and Symptoms in a Dry Eye Population.” The research presented in the poster demonstrates clear associations between demographics and dry eye sign and symptom severity. Kirk is a member of ARVO and a contributing author on two additional posters on Dry Eye Disease at the 2015 Annual Meeting.
Kirk joined SDC in January 2013 and currently serves as the Director of Biostatistics. Prior to joining SDC, he served as the Manager of Statistics at Bausch & Lomb, and previously as a Senior Biostatistician at PPD. He maintains an array of therapeutic area expertise including medical devices, ophthalmology, allergy, respiratory, cardiovascular, rheumatology, and oncology. Kirk holds a MS in Biostatistics from the University of Iowa and a BS in Statistics from Brigham Young University.
2015 ARVO Annual Meeting
May 3-6, 2015
Colorado Convention Center
700 14th St, Denver, CO 80202
Abstract
A Mixed Model, Repeated Measure Analysis of Demographics and Dry Eye Signs and Symptoms in a Dry Eye Population Kirk Bateman1 , George W. Ousler2 , Michael Watson2 , Keith J. Lane3 , Donna L. Welch2
1Statistics and Data Corporation, Tempe, AZ
2Dry Eye, Ora, Inc., Andover, MA
3R & D, Ora, Inc., Andover, MA.
Program Number: 4484 |Poster Board Number: A0110
Presentation Time: Wednesday, May 06, 2015, 11:00 AM-12:45 PM
Purpose: A multitude of risk factors influences the likelihood of developing dry eye signs and symptoms. A multivariate analysis was used to determine the association between demographic characteristics of age, gender, and duration of disease with the severity of dry eye signs and symptoms in a large population of dry eye clinical trial participants. The role of demographics may be important when designing dry eye clinical trials.
Methods: Subjects who had successfully completed at least one dry eye study were included in the analysis (N = 1343). A mixed-model, repeat-measure analysis was performed to assess the association of age, gender, and duration of disease with the severity of dry eye signs, as measured by clinician-graded baseline corneal fluorescein staining before and after a Controlled Adverse Environment (CAE) challenge, and with dry eye symptoms, as measured by subject diary-reported ocular discomfort and dryness scored during a placebo run-in period.
Results: The demographic criteria evaluated (age, gender, duration of disease) significantly affected dry eye sign and symptom severity (p < 0.05). Increased age was associated with a worsening of signs (inferior, superior, and central fluorescein staining). Increased duration of disease was associated with a worsening of both signs and symptoms of dry eye. Female gender was associated with a worsening of both clinical signs and a worsening of symptoms. There was a significant interaction between gender and duration of dry eye disease, with symptoms worsening with duration of disease among females.
Conclusions: The results of this study demonstrate clear associations between the demographic characteristics of age, gender, and duration of disease, and the severity of dry eye signs and symptoms. The findings of worsening of signs in older patients and with longer duration of disease are consistent with the literature. Increased severity of dry eye signs and symptoms in females is also consistent with previous findings. All three demographic criteria should be carefully considered in clinical trial design.
