Clinical trial NCT01635933: A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS
Official title: A Comparison of a Colored Silicone Hydrogel Lens Versus a Colored HEMA Lens
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: 370
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 evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .


Eligibility criteria: Inclusion Criteria:

* Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document.
* Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) ≥ 20/25 in each eye.
* Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye.
* Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day.
* History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS).
* 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 or prescribed topical ocular medications within the 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 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
* Participation in any investigational clinical study within previous 30 days.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Subjective Rating of Overall Comfort
timeFrame: Up to Day 28
Secondary outcomes:
measure: Subjective Rating of Overall Vision
timeFrame: Up to Day 28
measure: Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)
timeFrame: Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sharon Holden Thomas, O.D.
role: STUDY_DIRECTOR
References: