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

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: January 31, 2013
Last updated: April 25, 2014
Last verified: March 2014
The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.

Condition Intervention
Refractive Error
Device: Lotrafilcon B contact lens with color
Device: Phemfilcon A contact lens with color

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Official Title: A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Subjective Rating of Overall Satisfaction [ Time Frame: Day 7 ]
    Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating.

Secondary Outcome Measures:
  • Positive Purchase Intent [ Time Frame: Day 7 ]
    As reported on a questionnaire in response to, "Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses?" The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing "Definitely would purchase" or "Probably would purchase."

Enrollment: 574
Study Start Date: February 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIR OPTIX® COLORS
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.
Device: Lotrafilcon B contact lens with color
Silicone hydrogel contact lens with color
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.
Device: Phemfilcon A contact lens with color
Hydrogel contact lens with color


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01782482

Sponsors and Collaborators
Alcon Research
Study Director: Sharon Holden Thomas, O.D. Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT01782482     History of Changes
Other Study ID Numbers: C-12-003
Study First Received: January 31, 2013
Results First Received: February 18, 2014
Last Updated: April 25, 2014

Keywords provided by Alcon Research:
Color contact lenses
Refractive error

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases processed this record on April 26, 2017