A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS

NCT01635933 | Completed Results

• 1 other identifier: C-12-005
• Study Type: interventional
• Target: 370
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Myopia

Keywords

contact lenses; color contact lenses; myopia

Outcome Measures

Primary Outcomes (1)

• Subjective Rating of Overall Comfort

  Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.

  Up to Day 28

Secondary Outcomes (2)

• Subjective Rating of Overall Vision

  Up to Day 28

• Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)

  Day 28

Study Arms (2)

AIR OPTIX® COLORS

EXPERIMENTAL

Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.

Device: Lotrafilcon B contact lens with color

FRESHLOOK® COLORBLENDS

ACTIVE COMPARATOR

Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.

Device: Phemfilcon A contact lens with color

Interventions

Lotrafilcon B contact lens with color DEVICE

Silicone hydrogel contact lens with color.

Also known as: AIR OPTIX® COLORS

AIR OPTIX® COLORS

Phemfilcon A contact lens with color DEVICE

Hydrogel contact lens with color.

Also known as: FRESHLOOK® COLORBLENDS

FRESHLOOK® COLORBLENDS

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Sharon Holden Thomas, O.D., Sr. Principal Clinical Scientist
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sharon Holden Thomas, O.D.

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 9, 2014
• Results First Posted: March 28, 2014

Record last verified: 2014-04