Purpose: To evaluate how increasing age is associated with dry eye disease (DED) signs and symptoms in the Dry Eye Assessment and Management (DREAM) study. This study was undertaken to better understand how DED signs and symptoms differ across decades of life with goals to help assess detection and treatment of DED.
Design: Secondary analysis of the DREAM study.
Subjects: One hundred twenty, 140, 185, and 90 participants aged < 50, 50 to 59, 60 to 69, and 70 years, respectively
Methods: We performed a secondary analysis of data from the DREAM study, a multicenter randomized clinical trial, to evaluate the effect of omega-3 fatty acid supplementation for the treatment of DED. At baseline, 6 months, and 12 months follow-up, participants underwent an assessment of DED symptoms and signs using Ocular Surface Disease Index, Brief Pain Inventory, tear break-up time (TBUT) (in seconds), Schirmer test with anesthesia (mm/5 minutes), conjunctival staining, corneal staining, meibomian gland dysfunction evaluation, and tear osmolarity (mOsm/l). Multivariable generalized linear regression models were used to compare DED symptoms and signs across the 4 age groups among all participants and by sex
This is a secondary analysis of data from the DREAM study (ClinicalTrials.gov identifier, NCT02128763). The results of the DREAM study were previously published and showed that the active treatment group that received omega-3 supplementation did not show a significant difference in DED signs and symptoms compared with the placebo group that received olive oil pills.34 Briefly, 535 patients with moderate to severe DED and who were 18 years of age were enrolled in the study. All enrolled patients had moderate to severe DED symptoms for at least 6 months before the screening visit, use or desired use of artificial tears twice daily in the 2 weeks before the screening visit, and an Ocular Surface Disease Index (OSDI) score of 25 to 80 at the screening visit and 21 to 80 at the baseline visit. Full details on the inclusion and exclusion criteria and outcome measures can be found in the previously published primary results of the DREAM study.34 The study was approved by the institutional review board/ethics committee at each center (centers listed in Credit Roster for the DREAM study, available at www.opththalmologyscience.org), followed the tenets of the Declaration of Helsinki, and written informed consent was obtained from all patients.
Table 1 shows the comparison of baseline characteristics among the 4 age groups of DREAM participants. Across 4 age groups (< 50, 50e59, 60e69, 70 years), older age groups had a higher percent of White race (67.5% vs. 69.3% vs. 78.9% vs. 82.2%, P < 0.001) and a higher percent of non-Hispanic or Latino ethnicity (77.5% vs. 82.1% vs. 91.9% vs. 94.4%, P < 0.001). Older age groups had a lower percent of never smokers (80.8% vs. 69.3% vs. 66.5% vs. 55.6%, P < 0.001), a higher percent of self-reported ongoing peripheral artery disease (7.5% vs. 3.6% vs. 10.8% vs. 14.4%, P ¼ 0.002), and a higher percent of hypertension (12.5% vs. 16.4% vs. 20.0% vs. 21.1%, P < 0.001). Older age groups also had a higher percent with osteoarthritis (5.8% vs. 15.0% vs. 33.5% vs. 48.9%, P < 0.001), with hypercholesteremia (8.3% vs. 29.3% vs. 43.2% vs. 44.4%, P < 0.001), and taking statin medications (6.7% vs. 17.9% vs. 31.9% vs. 41.1%, P < 0.001) and a higher mean summary component measure of mental health (49.6 vs. 50.8 vs. 54.5 vs. 54.1, P < 0.001). Regarding treatment for dry eye, older age groups had a higher percent of using tears or gel (71.7% vs. 73.6% vs. 83.2% vs. 90.0%, P ¼ 0.002) and using more cyclosporine drops (10.0% vs. 20.7% vs. 23.2% vs. 23.3%, P ¼ 0.02) and warm liquid soaks (14.2% vs. 16.4% vs. 27.6% vs. 25.6%, P ¼ 0.01). They also used more other dry eye treatments beyond artificial tears or gel, cyclosporine drops, warm lid soaks, lid scrubs, or baby shampoo (21.7% vs. 30.7% vs. 38.9% vs. 38.9%, P ¼ 0.009).