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Evaluation of the Performance of AIR OPTIX® COLORS

Not Applicable
Completed
Conditions
Myopia
Registration Number
NCT01338402
Lead Sponsor
CIBA VISION
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
47
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Visual AcuityPhase 2: Up to Week 4
Conjunctival StainingPhase 2: Up to Week 4
Surface Regularity Index (SRI)Up to Phase 2, Week 4
Surface Asymmetry Index (SAI)Up to Phase 2, Week 4
Subjective ratingsPhase 2: Up to Week 4
Corneal StainingPhase 2: Up to Week 4
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Centre for Contact Lens Research, University of Waterloo

🇨🇦

Waterloo, Ontario, Canada

Centre for Contact Lens Research, University of Waterloo
🇨🇦Waterloo, Ontario, Canada

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