Tear Film Characteristics
Conditions
Brief summary
The CA-800 Corneal Analyzer (Visia Imaging S.R.L., Italy) is a device that can measure small imperfections in the tear film when the eyes are open. The goal of this study is to see if the device can detect changes in the tear film after instillation of an eye drop or when contact lenses are worn.
Interventions
DRUGSystane Complete Preservative-Free
One drop of Systane Complete Preservative Free will be instilled in each eye. Higher order aberrations assessed before and after instillation.
DEVICESenofilcon A
Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia. Higher order aberrations assessed before and after instillation.
DEVICESomofilcon A
Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia. Higher order aberrations assessed before and after instillation.
Sponsors
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Are at least 17 years of age and have full legal capacity to volunteer. 2. Have signed the information consent letter. 3. Are willing and able to follow instructions and maintain the appointment schedule. 4. Habitually wear spherical soft contact lenses (no multifocal lens, no toric lens wear or extended (overnight) wear). 5. Have a vertex-corrected refractive astigmatism of no more than 0.75D in each eye. 6. Achieve a best corrected visual acuity of 0.00 logMAR or better in each eye. 7. Agree to wear the study contact lenses for at least 6 hours. 8. Have clear corneas (e.g. no central scars). 9. Have no active ocular disease or inflammation.
Exclusion criteria
1. Are participating in another concurrent clinical research study. 2. Have worn any rigid contact lenses in the past 30 days. 3. Have been diagnosed with irregular cornea (e.g., keratoconus, etc.). 4. Have any known active ocular condition, disease, and/or infection.\* 5. Have a systemic or ocular condition that, in the opinion of the investigator, may affect a study outcome variable. 6. Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study. 7. Have undergone refractive error surgery. 8. Are a member of the study team for this study, i.e. are listed on the delegation log for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in higher order aberrations with an eye drop | Baseline (prior to instillation); immediately, 10, 20, 30, and 60 minutes post instillation of an eye drop | The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed. |
| Change in higher order aberrations with senofilcon A | Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens | The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed. |
| Change in higher order aberrations with somofilcon A | Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens | The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed. |
Countries
Canada
Contacts
Primary ContactJill Woods, MSc, MCOptom
Backup ContactLyndon Jones, PhD, DSc, FCOptom
Outcome results
None listed