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

NCT ID: NCT01635920

Last Updated: 2014-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-08-31

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).

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

AIR OPTIX® COLORS

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.

Group Type: EXPERIMENTAL

Lotrafilcon B contact lens with color

Intervention Type: DEVICE

Silicone hydrogel contact lens with color

AIR OPTIX® AQUA

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.

Group Type: ACTIVE_COMPARATOR

Lotrafilcon B contact lens

Intervention Type: DEVICE

Silicone hydrogel contact lens

Interventions

Lotrafilcon B contact lens with color

Silicone hydrogel contact lens with color

Intervention Type: DEVICE

Lotrafilcon B contact lens

Silicone hydrogel contact lens

Intervention Type: DEVICE

Other Intervention Names

AIR OPTIX® COLORS; AIR OPTIX® AQUA

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.

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Holden Thomas, O.D.

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-12-004

Identifier Type: -

Identifier Source: org_study_id