N/A
N=31
Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT02089191 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear — 22.84; 22.87 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nelfilcon A contact lenses (Device); Stenfilcon A contact lenses (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear |
22.84; 22.87 | — |
| SECONDARY Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear |
0.3; 0.2 | — |
Summary
The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.
Eligibility Criteria
Inclusion Criteria
- Must sign an Informed Consent form;
- Adapted, current soft contact lens wearer;
- Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D));
- Cylinder ≤ -1.00 D in both eyes at Visit 1;
- Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1;
- Willing to wear study lenses up to 12 hours and attend all study visits;
- Able to be successfully fitted with study lenses;
- Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Any 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 1 eye with functional vision) or fit with only 1 lens;
- Any abnormal ocular condition observed during Visit 1;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Pregnant or lactating;
- Participation in any clinical study within 30 days of Visit 1;
- Current MyDay® or DAILIES® AquaComfort Plus® lens wearer;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02089191). 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.