Clinical trial NCT01635920: A Comparison of Silicone Hydrogel Contact Lenses: AIR OPTIX® COLORS Versus AIR OPTIX® AQUA
Official title: A Comparison of Silicone Hydrogel Lenses: Colored Versus Non-Colored
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: contact lenses
color contact lenses
myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 258
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Detailed 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).

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.

Primary outcomes:
measure: Percentage of Subjects With Same Fit in Both Eyes
timeFrame: Up to Day 28
Secondary outcomes:
measure: Subjective Rating of Overall Comfort
timeFrame: Up to Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sharon Holden Thomas, O.D.
role: STUDY_DIRECTOR
References: