N/A
Completed N=251
A Comparison of Silicone Hydrogel Contact Lenses: AIR OPTIX® COLORS Versus AIR OPTIX® AQUA
Source: ClinicalTrials.gov NCT01635920 ↗Enrolled (actual)
251
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Subjects With Same Fit in Both Eyes — 99.2; 100; 99.2; 99.2 percentage of participants
Summary
The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Same Fit in Both Eyes |
99.2; 100; 99.2; 99.2 | — |
| SECONDARY Subjective Rating of Overall Comfort |
8.4; 8.9; 8.5; 8.9 | — |
Eligibility Criteria
Inclusion Criteria
- Visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity ≥ 20/25 in each eye.
- Manifest cylinder less than or equal to 0.75 diopter (D) (within the previous year) in each eye.
- Successful wear of AIR OPTIX® AQUA soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- Willing to sign an Informed Consent form. If under legal age of consent, legally authorized representative must also sign an Informed Consent form.
- 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 (OTC) or prescribed topical ocular medications within 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 that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
- Ocular or intra-ocular surgery within the previous 12 months (excluding placement of punctal plugs).
- Use of medications contributing to dry eye or ocular irritation unless on a stable dosing regimen for a minimum of 30 days prior to study entry and able to remain on stable regimen throughout the study.
- Participation in any investigational clinical study within previous 30 days.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01635920). 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.