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Trial record 2 of 2707 for:    color

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

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ClinicalTrials.gov Identifier: NCT02175199
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : October 14, 2015
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Myopia Device: Lotrafilcon B contact lenses with color printing Device: Phemfilcon A contact lenses with color printing Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Device: Lotrafilcon B contact lenses with color printing
Other Name: AIR OPTIX® COLORS
Active Comparator: 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.
Device: Phemfilcon A contact lenses with color printing
Other Name: FreshLook® COLORBLENDS®



Primary Outcome Measures :
  1. Lens Comfort Likert Response at Day 30 [ Time Frame: Day 30 ]
    Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only.


Secondary Outcome Measures :
  1. Lens Comfort Likert Response at Day 14 [ Time Frame: Day 14 ]
    Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure is prespecified for the AIR OPTIX COLORS arm only.

  2. Lens Comfort 1-10 Scale Response [ Time Frame: Day 30 ]
    Subject was instructed, "Please rate your comfort with the study lenses," using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Other protocol-specified inclusion criteria may apply.

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.
  • Other protocol-specified exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175199


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Global Brand Lead, GCRA, Vision Care Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02175199     History of Changes
Other Study ID Numbers: M-14-008
First Posted: June 26, 2014    Key Record Dates
Results First Posted: October 14, 2015
Last Update Posted: October 14, 2015
Last Verified: September 2015

Keywords provided by Alcon Research:
Contact lens
Vision care
Daily wear
Color contact lens