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OpenTrials
Completed

NCT Number: NCT01338402

Evaluation of the Performance of AIR OPTIX® COLORS

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Lotrafilcon B contact lens

Device

Silicone hydrogel contact lens

Other names: AIR OPTIX® AQUA

Lotrafilcon B contact lens with color

Device

Silicone hydrogel contact lens with color

Other names: AIR OPTIX® COLORS

Phemfilcon A contact lens with color

Device

Hydrogel contact lens with color

Other names: FRESHLOOK® COLORBLENDS

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

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Collaborators

  • University of Waterloo

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2011
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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