Evaluation of the Performance of AIR OPTIX® COLORS

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Lotrafilcon B contact lens; Device: Lotrafilcon B contact lens with color; Device: Phemfilcon A contact lens with color

• 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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-19
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-20

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

Arm && Interventions

Group	Intervention	Description
AIR OPTIX® AQUA	Lotrafilcon B contact lens	Lotrafilcon B contact lenses worn in both eyes on a daily wear basis for one week in Phase 1.
AIR OPTIX® COLORS	Lotrafilcon B contact lens with color	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.
FRESHLOOK® COLORBLENDS	Phemfilcon A contact lens with color	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.

Primary Outcome Measures

Name	Time	Method
Visual Acuity	Phase 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 ratings	Phase 2: Up to Week 4
Corneal Staining	Phase 2: Up to Week 4
Conjunctival Staining	Phase 2: Up to Week 4

Trial Locations

Locations (1)

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