N/A
Completed N=82
Clinical Evaluation of ACUVUE® OASYS® 1-Day and ACUVUE® OASYS®
Source: ClinicalTrials.gov NCT02696317 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH) — 11.97; 10.66; 8.51; 7.94 10^-7g/cm^2/s
Summary
The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH) |
11.97; 10.66; 8.51; 7.94 | — |
| SECONDARY Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH) |
11.51; 11.72; 8.78; 8.68 | — |
| SECONDARY Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH) |
84.64; 85.37 | — |
| SECONDARY Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH) |
94.14; 91.61 | — |
Eligibility Criteria
Inclusion Criteria
- Must sign an informed consent form;
- Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months;
- Prescription within power range of both study contact lenses, as stated in the protocol;
- Cylinder equal or lower than -0.75 diopter (D) in both eyes;
- Willing to wear lenses every day or at least a minimum of 5 days per week, 6 hours per day;
- Willing to discontinue artificial tears and rewetting drops 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 1 lens;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Pregnant or lactating;
- Current AO1D or AO lens wearer;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02696317). 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.