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

NCT01635920 | Completed Results

• 1 other identifier: C-12-004
• Study Type: interventional
• Target: 258
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Myopia

Keywords

contact lenses; color contact lenses; myopia

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Same Fit in Both Eyes

  Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. "Same fit" was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit.

  Up to Day 28

Secondary Outcomes (1)

• Subjective Rating of Overall Comfort

  Up to Day 28

Study Arms (2)

AIR OPTIX® COLORS

EXPERIMENTAL

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

Device: Lotrafilcon B contact lens with color

AIR OPTIX® AQUA

ACTIVE COMPARATOR

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

Device: Lotrafilcon B contact lens

Interventions

Lotrafilcon B contact lens with color DEVICE

Silicone hydrogel contact lens with color

Also known as: AIR OPTIX® COLORS

AIR OPTIX® COLORS

Lotrafilcon B contact lens DEVICE

Silicone hydrogel contact lens

Also known as: AIR OPTIX® AQUA

AIR OPTIX® AQUA

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:

• 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.

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 (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.

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: NONE
• 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: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 28, 2014
• Results First Posted: March 28, 2014

Record last verified: 2014-02