N/A
Completed N=147
AIR OPTIX® COLORS Registration Trial
Source: ClinicalTrials.gov NCT01440322 ↗Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) — 100.0; 100.0; 100.0; 98.0 Percentage of eyes
Summary
The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) |
100.0; 100.0; 100.0; 98.0; 100.0; 97.9 | — |
| SECONDARY Subjective Rating of Overall Vision |
8.3; 9.5; 8.0; 9.4; 8.1; 9.4 | — |
| SECONDARY Subjective Rating of Overall Comfort |
9.1; 9.2; 8.3; 9.0; 8.6; 9.3 | — |
| SECONDARY Subjective Rating of Overall Handling |
9.3; 9.5; 9.4; 9.2; 9.4; 9.4 | — |
| SECONDARY Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Lens Centration (Centered, Slight Decentration) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Dry Areas/Non-Wetting (None, Very Slight) |
100.0; 100.0; 100.0; 99.0; 99.4; 99.0 | — |
| SECONDARY Front Surface Deposits (None, Very Slight) |
100.0; 100.0; 96.7; 98.0; 97.8; 99.0 | — |
| SECONDARY Back Surface Deposits (None, Very Slight) |
100.0; 99.0; 100.0; 100.0; 99.4; 100.0 | — |
Eligibility Criteria
Inclusion Criteria
- Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- Normal eyes and not using any ocular medications.
- Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
- Manifest cylinder less than or equal to 0.75 diopter.
- Best spectacle corrected visual acuity greater than or equal to 20/25.
- Have current prescription glasses.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Anterior segment infection, inflammation, or abnormality.
- Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
- Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
- History of refractive surgery or irregular cornea.
- History of pathologically dry eye.
- Corneal vascularization greater than 1 millimeter of penetration.
- History of herpetic keratitis.
- Eye injury within 12 weeks immediately prior to enrollment in this trial.
- Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01440322). 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.