N/A
N=45
Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT02289742 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear — 55.8; 47.2; 46.5; 49.5 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nelfilcon A multifocal contact lenses (Device); Nelfilcon A toric contact lenses (Device); Nelfilcon A sphere contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear |
55.8; 47.2; 46.5; 49.5 | — |
| SECONDARY Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear |
60.8; 46.3; 34.3; 33.3 | — |
Summary
The purpose of this study is to evaluate the pre lens tear film characteristics of DAILIES® Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.
Eligibility Criteria
Inclusion Criteria
- Must sign an informed consent document;
- Adapted, current soft contact lens wearer with either:
- A spectacle add between +0.50 and +2.50 (inclusive) [Presbyopes group]
- A spherical correction of an astigmatism up to 20% of the amount of the sphere [Astigmats group];
- Contact lens prescription in the power range specified in the protocol;
- Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;
- Willing to wear study lenses up to 12 hours and attend all study visits;
- Can be successfully fitted with study lenses;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any 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;
- 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 the Visit 1 slit-lamp examination;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Pregnant or lactating;
- Unstable tear film with a NIK-BUT value below 8 seconds in either eye without lenses;
- Participation in any clinical study within 30 days of Visit 1;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02289742). 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.