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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01782482
First received: January 31, 2013
Last updated: April 25, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Myopia
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 (Subject)
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Other Name: AIR OPTIX® COLORS
Active Comparator: FRESHLOOK® COLORBLENDS
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
Other Name: FRESHLOOK® COLORBLENDS

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782482

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Color contact lenses
Refractive error
Myopia

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014