DAILIES Total1® Lubricity Post Wear
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/3/2014 |
Start Date: | March 2014 |
End Date: | March 2014 |
Contact: | Alcon Call Center |
Email: | alcon.medinfo@alcon.com |
Phone: | 1-888-451-3937 |
Evaluation of the Lubricity of DAILIES Total1® Contact Lenses After Wear
The primary objective of the study is to demonstrate that the lubricity of DAILIES Total1®
(DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.
(DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.
In this crossover study, participants will attend 3 visits. Each participant will wear study
lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized)
following which lenses will be collected for ex vivo lubricity analysis. The ex vivo
lubricity analysis will be evaluated under a separate non-clinical protocol.
lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized)
following which lenses will be collected for ex vivo lubricity analysis. The ex vivo
lubricity analysis will be evaluated under a separate non-clinical protocol.
Inclusion Criteria:
- Willing and able to sign Informed Consent document.
- Adapted, current soft contact lens wearer.
- Requires contact lens powers within the specified range of -0.50 to -10.00 diopters
(D).
- Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest
refraction.
- Vision correctable to 20/25 or better in each eye at distance with study lenses.
- Willing to wear study lenses at least 16 waking hours in one day and attend all study
visits.
- Able to be successfully fitted with study lenses.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Any ocular infection, inflammation, abnormality or active disease that would
contraindicate contact lens wear, as determined by the Investigator.
- Use of systemic or ocular medications for which contact lens wear could be
contraindicated, as determined by the Investigator.
- Use of artificial tears and rewetting drops during the study.
- Monocular (only one eye with functional vision) or fit with only one lens.
- Any abnormal ocular condition observed during the Visit 1 slit lamp examination.
- History of herpetic keratitis, ocular surgery, or irregular cornea.
- Pregnant.
- Participation in any clinical study within 30 days of Visit 1.
- Other protocol-specified exclusion criteria may apply.
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