Clinical trial NCT01440322: AIR OPTIX® COLORS Registration Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: Myopia
Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-09-26
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed description: This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.

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.

Primary outcomes:
measure: Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
timeFrame: Up to Month 3
Secondary outcomes:
measure: Subjective Rating of Overall Vision
timeFrame: Up to Month 3
measure: Subjective Rating of Overall Comfort
timeFrame: Up to Month 3
measure: Subjective Rating of Overall Handling
timeFrame: Up to Month 3
measure: Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
timeFrame: Up to Month 3
measure: Lens Centration (Centered, Slight Decentration)
timeFrame: Up to Month 3
measure: Dry Areas/Non-Wetting (None, Very Slight)
timeFrame: Up to Month 3
measure: Front Surface Deposits (None, Very Slight)
timeFrame: Up to Month 3
measure: Back Surface Deposits (None, Very Slight)
timeFrame: Up to Month 3
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sharon Holden Thomas, OD
role: STUDY_DIRECTOR
References: