Dry Eye
Conditions
Keywords
eye, eyelid, contact lenses, dry eye disease
Brief summary
The purpose of this study is to assess eyelid margin staining, termed lid wiper epitheliopathy (LWE), in three populations. The hypothesis is LWE will be more prevalent in symptomatic contact lens wearers than non-symptomatic contact lens wearers and least prevalent in asymptomatic non-contact lens wearers.
Interventions
OTHEROphthalmic dye
Topically instilled for the purpose of assessing lid margin staining
DEVICEContact lenses
Silicone hydrogel contact lenses per subject's habitual brand and power, worn for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled.
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Has full legal capacity to volunteer; * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Has had an ocular examination in the last two years; * Has clear corneas and no active ocular disease; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Has any ocular disease; * Has a systemic condition that may affect a study outcome variable; * Is using any systemic or topical medications that may affect ocular health; * Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; * Has undergone corneal refractive surgery; * Currently wears contact lenses on an extended wear basis (overnight); * Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LWE-associated staining score | 3 minutes after dye instillation | Lens wearers must wear lenses for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled. LWE-associated staining will be assessed by the investigator and reported as a composite score based on Korb's method. |
Countries
Canada
Outcome results
None listed