N/A
N=198
Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS
Cosmetic Appearance
Bottom Line
View on ClinicalTrials.gov: NCT01398787 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Overall Preference — 49.1; 24.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lotrafilcon B contact lens with color (Device); Phemfilcon A contact lens with color (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- CIBA VISION
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Preference |
49.1; 24.6 | — |
| PRIMARY Initial Comfort Preference |
55.1; 23.4 | — |
| PRIMARY Appearance Preference |
36.5; 23.4 | — |
| PRIMARY Subjective Rating of Initial Comfort |
8.6; 7.5 | — |
| PRIMARY Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree) |
84.9; 77.0; 78.9; 81.3; 81.3; 75.8 | — |
| PRIMARY Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy) |
80.2; 59.9 | — |
Summary
The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK® COLORBLENDS contact lens wearers.
Eligibility Criteria
Inclusion Criteria
- Sign written Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- Have spectacles that provide acceptable near vision to wear over study lenses as needed to evaluate cosmetics of the lenses.
- Habitually wear FRESHLOOK® COLORBLENDS lenses at least two days per week.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Eye injury or surgery within twelve weeks of enrollment in this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Evidence of systematic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01398787). 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.