Purpose: To determine if rating of ocular comfort during soft contact lens wear is affected by demographic factors.
Methods: Retrospective analysis of ocular comfort ratings during soft contact lens wear extracted from 44 nonrandomized similar clinical trials (n = 986). Subjects wore one of seven daily wear silicone hydrogels (SiHy) in combination with one of nine lens care products (LCP), and two daily disposables lenses. The effects on comfort rating of demographic factors were examined after adjusting for lens and LCP effects using general linear model.
Results: Males reported lower comfort on insertion than females (7.9 ± 1.6 vs. 8.1 ± 1.6, p = 0.001). Over 45 years old had higher comfort ratings than those between 26 and 45 or <26 years old at insertion (8.7 ± 1.3 vs. 8.1 ± 1.6 vs. 7.8 ± 1.6, p < 0.001), during the day (8.6 ± 1.2 vs. 8.0 ± 1.6 vs. 8.2 ± 1.2, p < 0.001), and end of day (7.7 ± 1.6 vs. 6.8 ± 2.0 vs. 7.0 ± 1.6, p < 0.001). Neophytes reported lower comfort on insertion (7.3 ± 1.6 vs. 8.2 ± 1.5, p < 0.001) and during day (8.0 ± 1.3 vs. 8.3 ± 1.3, p = 0.020) than experienced wearers. Participants with Rx ≥-3.50D had higher comfort ratings than those with ≤-3.50D on insertion (8.3 ± 1.4 vs. 7.8 ± 1.6, p < 0.001), during the day (8.4 ± 1.3 vs. 8.1 ± 1.3, p = 0.010), and end of day (7.2 ± 1.7 vs. 6.9 ± 1.8, p = 0.046). Comfort during the day was different between participants of different ethnic origin (p = 0.024) with Asians reporting the lowest (8.1 ± 1.3).
Conclusions: Demographic factors such as age, gender, lens wear experience, ethnicity, and refractive status can influence the rating of ocular comfort in clinical studies. The confounding effects of such demographic factors can be controlled by implementing randomization and appropriate multivariable statistical analysis.