title: Cutoff score and responsiveness of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) in a Large daily disposable contact lens registry.
abstract: OBJECTIVE
  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.
authors.affiliation: 2097 East Lake Rd., Atlanta, GA 30307, United States. Electronic address: chalmers2097@gmail.com.
authors.forename: Robin L
authors.initials: RL
authors.lastname: Chalmers
authors.affiliation: 2097 East Lake Rd., Atlanta, GA 30307, United States.
authors.forename: Lisa
authors.initials: L
authors.lastname: Keay
authors.affiliation: 2097 East Lake Rd., Atlanta, GA 30307, United States.
authors.forename: Sheila B
authors.initials: SB
authors.lastname: Hickson-Curran
authors.affiliation: 2097 East Lake Rd., Atlanta, GA 30307, United States.
authors.forename: William J
authors.initials: WJ
authors.lastname: Gleason
mesh_terms: D000328:Adult; D017677:Age Distribution; D003263:Contact Lenses, Hydrophilic / Q000706:statistics & numerical data*; D004209:Disposable Equipment / Q000706:statistics & numerical data*; D015352:Dry Eye Syndromes / Q000175:diagnosis* / Q000453:epidemiology*; D005260:Female; D006801:Humans; D008297:Male; D015995:Prevalence; D011594:Psychometrics / Q000379:methods; D012042:Registries; D015203:Reproducibility of Results; D057566:Self Report; D012680:Sensitivity and Specificity; D017678:Sex Distribution; D011795:Surveys and Questionnaires; D014481:United States / Q000453:epidemiology
keywords: CLDEQ-8; Clinically important difference; Contact lens symptoms; Daily disposable; Questionnaires