AIR OPTIX® COLORS Registration Trial

Ciba Vision

Status: Completed

Conditions: Refractive Error

Treatments: Device: Lotrafilcon B contact lens with color; Device: Lotrafilcon B contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01440322

P-383-C-003 (C-11-032)

Details and patient eligibility

About

The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.

Full description

This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
• Normal eyes and not using any ocular medications.
• Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
• Manifest cylinder less than or equal to 0.75 diopter.
• Best spectacle corrected visual acuity greater than or equal to 20/25.
• Have current prescription glasses.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Anterior segment infection, inflammation, or abnormality.
• Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
• Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
• History of refractive surgery or irregular cornea.
• History of pathologically dry eye.
• Corneal vascularization greater than 1 millimeter of penetration.
• History of herpetic keratitis.
• Eye injury within 12 weeks immediately prior to enrollment in this trial.
• Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days.
• Other protocol-defined exclusion criteria may apply.

Trial design

150 participants in 2 patient groups

AIR OPTIX® COLORS

Experimental group

Description:

Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months

Treatment:

Device: Lotrafilcon B contact lens with color

AIR OPTIX® AQUA

Active Comparator group

Description:

Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months

Treatment:

Device: Lotrafilcon B contact lens