A Comparison of Silicone Hydrogel Contact Lenses: AIR OPTIX® COLORS Versus AIR OPTIX® AQUA

Alcon

Status

Completed

Conditions

Myopia

Treatments

Device: Lotrafilcon B contact lens

Device: Lotrafilcon B contact lens with color

Study type

Interventional

Funder types

Industry

Identifiers

NCT01635920

C-12-004

Details and patient eligibility

About

The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses.

Full description

Eligible participants were randomized at Visit 1 (Screening) to receive 1 of the 2 investigational products (1:1 assignment). Between Visit 1 and Visit 2, participants wore their habitual AIR OPTIX® AQUA lenses. Investigational products were dispensed at Visit 2 (Baseline), after which participants were asked to return for 2 additional visits: Visit 3 (Day 14) and Visit 4 (Day 28).

Enrollment

258 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.