Evaluation of the Performance of AIR OPTIX® COLORS

NCT01338402 — Not applicable, Completed, 47 participants, CIBA VISION

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Registry	NCT01338402
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: single
Enrollment	47 (Actual)
Sponsor	CIBA VISION (Industry); collaborators: University of Waterloo
Conditions	Myopia
Interventions	Lotrafilcon B contact lens, Lotrafilcon B contact lens with color, Phemfilcon A contact lens with color (Device)
Dates	start 2011-04-01, primary completion 2012-03-01, completion 2012-03-01, first posted 2011-04-19, last updated 2014-02-20
Locations	1 site in Canada

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
AIR OPTIX® AQUA	Other	Device: 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	Experimental	Device: 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	Active comparator	Device: 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.

Lotrafilcon B contact lens (Device), also known as AIR OPTIX® AQUA: Silicone hydrogel contact lens
Lotrafilcon B contact lens with color (Device), also known as AIR OPTIX® COLORS: Silicone hydrogel contact lens with color
Phemfilcon A contact lens with color (Device), also known as FRESHLOOK® COLORBLENDS: Hydrogel contact lens with color

+Outcome measures

Primary outcomes

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]

+Eligibility

Sex: All, ages: 17 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Centre for Contact Lens Research, University of Waterloo	Waterloo, Ontario	Canada

+Investigators

Desmond Fonn, MOptom, FAAO, Principal investigator, University of Waterloo Centre for Contact Lens Research
Lyndon Jones, PhD, FCOptom, FAAO, Principal investigator, University of Waterloo Centre for Contact Lens Research