A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers

NCT ID: NCT02175199

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-09-30

Brief Summary

The purpose of this study is to evaluate the comfort of color contact lenses in a population of clear contact lens wearers who have an interest in wearing color contact lenses.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

AIR OPTIX COLORS

Lotrafilcon B contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.

Group Type: EXPERIMENTAL

Lotrafilcon B contact lenses with color printing

Intervention Type: DEVICE

FreshLook COLORBLENDS

Phemfilcon A contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.

Group Type: ACTIVE_COMPARATOR

Phemfilcon A contact lenses with color printing

Intervention Type: DEVICE

Interventions

Lotrafilcon B contact lenses with color printing

Intervention Type: DEVICE

Phemfilcon A contact lenses with color printing

Intervention Type: DEVICE

Other Intervention Names

AIR OPTIX® COLORS; FreshLook® COLORBLENDS®

Eligibility Criteria

Inclusion Criteria

• Willing to sign an Informed Consent Document or Assent, if applicable.
• Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses.
• Manifest cylinder (at screening) less than or equal to 0.75 diopters (D) in each eye.
• Successful wear of clear/handling tint, single-vision spherical, bi-weekly/ monthly replacement soft contact lenses in both eyes during the past 2 months for a minimum of 5 days per week and 8 hours per day.
• Requires spherical contact lenses within the available range of powers (i.e.,-1.50D to -5.00D in 0.25D steps).
• Interested in wearing contact lenses that change the appearance of the color of the eyes.

Exclusion Criteria

• Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current).
• History of herpetic keratitis.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear, except for rewetting drops.
• Corneal vascularization greater than 1 millimeter (mm) of penetration.
• Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
• Previous corneal or refractive surgery or irregular cornea.
• Monovision and monocular (only 1 eye with functional vision) or fit with only 1 lens.
• Anisometropia ≥1.50D (study contact lens prescription).
• History of intolerance or hypersensitivity to any component of the test articles.
• Eye injury or ocular or intra-ocular surgery within the last 6 months (excluding placement of punctal plugs).
• Participation in any clinical study within 30 days of Visit 1.

• 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

Global Brand Lead, GCRA, Vision Care

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

M-14-008

Identifier Type: -

Identifier Source: org_study_id