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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Lotrafilcon B contact lens with color; Device: Lotrafilcon B contact lens; Device: Phemfilcon A contact lens with color

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Silicone hydrogel contact lens; Other Names: AIR OPTIX® AQUA
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; Silicone hydrogel contact lens with color; Other Names: AIR OPTIX® COLORS
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; Hydrogel contact lens with color; Other Names: FRESHLOOK® COLORBLENDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Acuity	Phase 2: Up to Week 4
Corneal Staining	Phase 2: Up to Week 4
Conjunctival Staining	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

Collaborators and Investigators

• Sponsor: CIBA VISION
• Collaborators: University of Waterloo
• Investigators: Principal Investigator: Desmond Fonn, MOptom, FAAO, University of Waterloo Centre for Contact Lens Research; Principal Investigator: Lyndon Jones, PhD, FCOptom, FAAO, University of Waterloo Centre for Contact Lens Research

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: April 15, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (ESTIMATE): April 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 20, 2014
• Last Update Submitted That Met QC Criteria: February 19, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P-368-C-108; P/363/10/C (OTHER: University of Waterloo)