Evaluation of the Performance of AIR OPTIX® COLORS

NCT01338402 | Completed

• 2 other identifiers: P-368-C-108P/363/10/C
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

AIR OPTIX® AQUA

OTHER

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

Device: Lotrafilcon B contact lens

AIR OPTIX® COLORS

EXPERIMENTAL

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

FRESHLOOK® COLORBLENDS

ACTIVE COMPARATOR

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

Lotrafilcon B contact lens DEVICE

Silicone hydrogel contact lens

Also known as: AIR OPTIX® AQUA

AIR OPTIX® AQUA

Lotrafilcon B contact lens with color DEVICE

Silicone hydrogel contact lens with color

Also known as: AIR OPTIX® COLORS

AIR OPTIX® COLORS

Phemfilcon A contact lens with color DEVICE

Hydrogel contact lens with color

Also known as: FRESHLOOK® COLORBLENDS

FRESHLOOK® COLORBLENDS

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• CIBA VISION: lead
• University of Waterloo: collaborator

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

CA (1)