N/A
Completed N=167
Comparison of Two Marketed Silicone Hydrogel Lenses
Source: ClinicalTrials.gov NCT02495948 ↗Enrolled (actual)
167
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear — 1.63; 4.89 micrograms
Summary
The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear |
1.63; 4.89 | — |
Eligibility Criteria
Inclusion Criteria
- Sign informed consent document;
- Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
- Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
- Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
- History of herpetic keratitis, corneal surgery or irregular cornea;
- Any use of systemic or ocular medications within the past 30 days 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;
- Current or past AIR OPTIX® AQUA or ULTRA lens wearers;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02495948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.