Abstract
Purpose: :
To select a streamlined set of questions from the Contact Lens Dry Eye Questionnaire (CLDEQ) that best reflect status and change in Overall Opinion of contact lens performance.
Methods: :
Subjects (n=38) in an IRB-approved 4-week randomized cross-over daily wear CL study completed the CLDEQ along with a question on Overall Opinion of CL performance at baseline and 1 and 2 weeks after cross-over to 2 silicone hydrogel lens types; senofilcon A (Acuvue OASYS) and balafilcon A (Purevision). The sample included healthy current CL wearers who had been in their current lens type for at least 6 months. Individual items from the CLDEQ were first tested to determine those with the best correlation to OO (Spearman). From the subset of highly correlated items, a subset of 8 questions was tested to establish its ability to reflect change in Overall Opinion after refitting. Maximum CLDEQ-8 score is 35 (higher is worse).
Results: :
Frequency and late day (PM) intensity of Discomfort, Dryness and Blurry Vision that clears with a blink were all significantly and highly correlated with OO after randomization in the study. Mean±SD CLDEQ-8 scores were Baseline = 11.2±6.0, 1 and 2 week senofilcon A = 8.0±6.2 and 8.7±6.5; 1 and 2 week balafilcon A 14.8 ±8.4 and 15.6±8.1 (p ≤ 0.009 all comparisons except 1 vs 2 weeks). In addition, when change in CLDEQ-8 scores was analyzed by the change from Baseline Overall Opinion at one visit there were significant differences between groups: Improved -6.9±6.7; No Change -3.9±5.6; Worse 2.9±4.5; (ANOVA, F=10.9, p<0.001).
Conclusions: :
Contact lens clinical practice is hampered by unresponsive yet unrepeatable objective clinical tests to assess changes in CL performance. The CLDEQ-8 score (comprised of summing the Frequency and PM intensity of Dryness, Discomfort and Blurry Vision; plus the Frequency of "Closing the Eyes to Rest Them" and "Removing CLs to Relieve Discomfort") significantly reflected the change in Overall Opinion regarding CL performance among these silicone hydrogel CL wearers.
Clinical Trial: :
www.clinicaltrials.gov NCT00700752