Evaluation of the Performance of AIR OPTIX® COLORS

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338402
• Other study ID #: P-368-C-108
• Secondary ID: P/363/10/C
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: February 19, 2014
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: February 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon B contact lens
Silicone hydrogel contact lens
• Lotrafilcon B contact lens with color
Silicone hydrogel contact lens with color
• Phemfilcon A contact lens with color
Hydrogel contact lens with color

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
CIBA VISION	University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity		Phase 2: Up to Week 4	No
Primary	Corneal Staining		Phase 2: Up to Week 4	No
Primary	Conjunctival Staining		Phase 2: Up to Week 4	No
Primary	Surface Regularity Index (SRI)		Up to Phase 2, Week 4	No
Primary	Surface Asymmetry Index (SAI)		Up to Phase 2, Week 4	No
Primary	Subjective ratings		Phase 2: Up to Week 4	No