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

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Alcon

Status

Completed

Conditions

Myopia
Refractive Error

Treatments

Device: Phemfilcon A contact lens with color
Device: Lotrafilcon B contact lens with color

Study type

Interventional

Funder types

Industry

Identifiers

NCT01782482
C-12-003

Details and patient eligibility

About

The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.

Enrollment

574 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document.
  • Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance.
  • Manifest cylinder less than or equal to 0.75 diopter in each eye.
  • Wear contact lenses within protocol-defined specifications.
  • Require spherical contact lenses within the available range of powers.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Any eye condition that contraindicates contact lens wear.
  • Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • Moderate or severe ocular findings upon examination.
  • Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops.
  • 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.
  • Eye injury or surgery within the last 6 months (excluding placement of punctal plugs).
  • Monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
  • History of intolerance or hypersensitivity to any component of the test articles.
  • Other protocol-defined exclusion criteria may apply.

Trial design

574 participants in 2 patient groups

AIR OPTIX® COLORS
Experimental group
Description:
Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
Treatment:
Device: Lotrafilcon B contact lens with color
FRESHLOOK® COLORBLENDS
Active Comparator group
Description:
Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
Treatment:
Device: Phemfilcon A contact lens with color

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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