Cutoff score and responsiveness of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) in a Large daily disposable contact lens registry.

PURPOSE: To report (1) results of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) among a large sample of SCL wearers before and during 1 year after fitting with one of 2 daily disposable (DD) lenses (etafilcon A or narafilcon B) in the TEMPO Registry, (2) the cut-off score to identify highly symptomatic SCL wearers and (3) the clinically important difference (CID) in the CLDEQ-8 score. METHODS: Demographics, CL history and patterns of SCL use were documented. Construct validity of the CLDEQ-8 was tested versus overall opinion (OO) of habitual SCLs, eye dryness and eye sensitivity at baseline. Responsiveness to change in OO was tested. Cutoff score, CID, and predictive accuracy were analyzed with general linear mixed models, adjusting for clustering by site with Bonferoni correction for multiple comparisons. RESULTS: Baseline CLDEQ-8 data from 977 habitual SCL wearers showed significant association with OO, eye dryness and sensitivity (p<0.0001, all). CLDEQ-8 scores improved significantly after refitting and reflected change in OO over time (p<0.0001). Diagnostic cutoff of≥12 and CID of 3 points performed best. CONCLUSIONS: The CLDEQ-8 score of ≥12 points is proposed to identify SCL wearers who could benefit from clinical management of their CL-related symptoms. The clinically important difference was ±3 points. Refitting to these DD lenses in the TEMPO Registry provided significant and stable reduction in SCL-related symptoms across the year of follow-up. Use of the CLDEQ-8 in clinical practice and clinical research will help quantify and standardize symptom measures in SCL wearers.

Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry.

PURPOSE: To report annualized adverse events (AEs) including corneal infiltrative events (CIEs) with use of silicone hydrogel (SiHyDD) and hydrogel daily disposable (HydDD) soft contact lenses (SCLs) in the 1•DAY ACUVUE TruEye or 1•DAY ACUVUE MOIST Performance Overview (TEMPO) Registry (NCT01467557). METHODS: Annualized incidence of symptomatic daily disposable (DD)-related AEs was calculated from 3064 surveys from 1171 subjects (601 SiHyDD and 570 HydDD, 31.8 ± 13.5 years, 68% female) during 1 year. Three independent experts adjudicated potential AE cases. Demographics were compared between wearers with and without AEs. RESULTS: The registry tracked 960.3 years of lens wear: SiHyDD 489.4 years and HydDD 470.9 years. In that period, the 601 SiHyDD wearers reported eight AEs with office visits (1.6%/y; 2 CIEs, 0.4%/y), eight (1.6%/y) without office visits, and four AEs unrelated to SCLs (0.8%/y) (SiHyDD wearers with AEs; 44.8 ± 12.5 years; 75% female). The 570 HyDD wearers reported three AEs with office visits (0.6%/y; no CIEs), five without office visits (1.1%/y), and one non-SCL-related AE (0.2%/y) (HydDD wearers with AEs; 26.3 ± 8.0 years; 100% female). These CIE rates are significantly lower than the lowest estimate of 3.3% from prior studies. Wearers with SiHyDD-related AEs were significantly older than unaffected wearers (P = 0.02), but not for HydDD-related AEs. CONCLUSIONS: The CIE rates of 0.4% and 0% with these DD lenses are significantly lower than rates reported with reusable SCLs (3%-4%/y), indicating improved safety outcomes with these DD lenses. Compared to unaffected wearers, SiHyDD lens wearers with AEs requiring clinical visits were significantly older. (ClinicalTrials.gov number, NCT01467557.).