N/A
N=363
A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01635933 ↗Enrolled (actual)
363
Serious AEs
0.8%
Results posted
Mar 2014
Primary outcome: Primary: Subjective Rating of Overall Comfort — 8.7; 8.6; 8.7; 8.5 Units on a scale
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 · 16+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Rating of Overall Comfort |
8.7; 8.6; 8.7; 8.5 | — |
| SECONDARY Subjective Rating of Overall Vision |
8.8; 8.7; 8.9; 8.7 | — |
| SECONDARY Proportion of Subjects Preferring Study Lens (Strongly or Somewhat) |
54.3; 45.2 | — |
Summary
The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .
Eligibility Criteria
Inclusion Criteria
- Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document.
- Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) ≥ 20/25 in each eye.
- Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye.
- Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day.
- History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS).
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
- Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
- Monovision, monocular (only one eye with functional vision) or fit with only one lens.
- History of intolerance or hypersensitivity to any component of the test articles.
- Use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops).
- Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications; and any corneal infiltrates.
- Current or history of ocular infection, severe inflammation, or disease within previous 6 months.
- Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
- Participation in any investigational clinical study within previous 30 days.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01635933). 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.