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CompletedNCT01338402Updated Feb 20, 2014

Evaluation of the Performance of AIR OPTIX® COLORS

An interventional study of Lotrafilcon B contact lens and Lotrafilcon B contact lens with color in Myopia, sponsored by CIBA VISION. Completed at 1 site in Canada. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2014-02-20.

Sponsored by CIBA VISION · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
17 Years and older
Sex
All
01

Study summary

The purpose of this study was to assess the ocular response to and performance of the cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS.

Read the detailed description

The study was conducted in two phases. Phase 1 was an adaptation phase where participants wore AIR OPTIX® AQUA contact lenses bilaterally (same product in both eyes) on a daily wear basis for 1 week. In Phase 2, participants wore AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS contact lenses contralaterally (different product in each eye) on a daily wear basis for 4 weeks.

02

Conditions studied

  • Myopia

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 47 is below the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

CIBA VISION is the lead sponsor of 51 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Full legal capacity to volunteer;
  • Read and sign information and consent letter;
  • Willing and able to follow instructions and maintain the appointment schedule;
  • Ocular examination in the last two years;
  • Currently wears soft contact lenses on a daily wear basis;
  • Contact lens prescription between -1.50 diopters and -5.00 diopters;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

  • Any ocular disease;
  • Any systemic condition that may affect a study outcome variable;
  • Any systemic or topical medications that may affect ocular health;
  • Known sensitivity to the diagnostic pharmaceuticals used in the study;
  • Unable to achieve an acceptable fit with the study lenses;
  • Anisometropia >1.00 diopter or astigmatism >0.75 diopter;
  • Use of lubricating/rewetting eye drops.
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
47 participants (actual)

Study arms

  • Other
    AIR OPTIX® AQUA

    Lotrafilcon B contact lenses worn in both eyes on a daily wear basis for one week in Phase 1.

    Device: Lotrafilcon B contact lens

  • Experimental
    AIR OPTIX® COLORS

    Lotrafilcon B contact lens with color randomly assigned to one eye, with phemfilcon A contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit.

    Device: Lotrafilcon B contact lens with color

  • Active comparator
    FRESHLOOK® COLORBLENDS

    Phemfilcon A contact lens with color randomly assigned to one eye, with lotrafilcon B contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit.

    Device: Phemfilcon A contact lens with color

Interventions

  • DeviceLotrafilcon B contact lens

    Silicone hydrogel contact lens

    Also known as: AIR OPTIX® AQUA

  • DeviceLotrafilcon B contact lens with color

    Silicone hydrogel contact lens with color

    Also known as: AIR OPTIX® COLORS

  • DevicePhemfilcon A contact lens with color

    Hydrogel contact lens with color

    Also known as: FRESHLOOK® COLORBLENDS

06

What researchers measure

Primary outcomes

  1. Visual Acuity

    Time frame: Phase 2: Up to Week 4

  2. Corneal Staining

    Time frame: Phase 2: Up to Week 4

  3. Conjunctival Staining

    Time frame: Phase 2: Up to Week 4

  4. Surface Regularity Index (SRI)

    Time frame: Up to Phase 2, Week 4

  5. Surface Asymmetry Index (SAI)

    Time frame: Up to Phase 2, Week 4

  6. Subjective ratings

    Time frame: Phase 2: Up to Week 4

07

Study locations

1 site
  • Centre for Contact Lens Research, University of Waterloo
    Waterloo, Ontario N2L 3G1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01338402
Lead sponsor
CIBA VISION
Collaborators
University of Waterloo
Responsible party
Sponsor
First posted
Apr 19, 2011
Start date
Apr 2011
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Feb 20, 2014

Study contacts

Desmond Fonn, MOptom, FAAO
principal investigator · University of Waterloo Centre for Contact Lens Research
Lyndon Jones, PhD, FCOptom, FAAO
principal investigator · University of Waterloo Centre for Contact Lens Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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