DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | September 2015 |
End Date: | April 2016 |
Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids
The purpose of this study is to evaluate the tear film evaporation of symptomatic soft
contact lens wearers in the absence of contact lens wear and after at least 8 hours of
contact lens wear.
contact lens wearers in the absence of contact lens wear and after at least 8 hours of
contact lens wear.
This study will consist of 5 visits (1 screening, 4 assessment) with a maximum of 6 days
between assessment visits with at least 24 hours of no lens wear the day prior to the visit.
Each subject will be randomized to wear 3 different study lenses for at least 8 hours each
and one 8 hour day of no lens wear in a specific sequence. This study will be conducted in
Australia.
between assessment visits with at least 24 hours of no lens wear the day prior to the visit.
Each subject will be randomized to wear 3 different study lenses for at least 8 hours each
and one 8 hour day of no lens wear in a specific sequence. This study will be conducted in
Australia.
Inclusion Criteria:
- Sign an informed consent document;
- Adapted, current soft contact lens wearer;
- Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility)
Questionnaire;
- Can be successfully fitted with study lenses;
- Willing to wear lenses for a minimum of 8 hours prior to each study visit;
- Willing to discontinue artificial tears and rewetting drops usage on the days of study
visits;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Ocular anterior segment infection, inflammation, abnormality, or active disease that
would contraindicate contact lens wear;
- Use of systemic or ocular medications for which contact lens wear could be
contraindicated as determined by the investigator;
- Monocular (only 1 eye with functional vision) or fit with only one lens;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Known pregnancy and lactation;
- Other protocol-specified exclusion criteria may apply.
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