A Comparison of Manufacturing Processes for AIR OPTIX® COLORS Contact Lens

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Lotrafilcon B contact lens with color, semi-automated; Device: Lotrafilcon B contact lens with color, automated

Study type: Interventional

Funder types: Industry

Identifiers

NCT01614678

P-383-C-005/C-12-026

C-12-026 (Other Identifier)

Details and patient eligibility

About

The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured using a semi-automatic process.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able and willing to sign a written Informed Consent form.
• Cylinder ≤ -0.75 diopter (D).
• Able to achieve visual acuity (VA) of at least 20/30 Snellen in each eye at distance with contact lenses (CLCVA) and best corrected visual acuity (BCVA) ≥ 20/25.
• Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
• Successful daily wear of single-vision spherical soft contact lenses in both eyes during the past 3 months for a minimum of 8 hours/day, 5 days/week.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks immediately prior to enrollment in this trial.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in an ophthalmic clinical trial.
• Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions, as determined by the investigator.
• Pathologically dry eye.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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49 participants in 2 patient groups

AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto

Other group

Description:

Lotrafilcon B contact lens with color, automated, worn first, with Lotrafilcon B contact lens with color, semi-automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.

Treatment:

Device: Lotrafilcon B contact lens with color, automated

Device: Lotrafilcon B contact lens with color, semi-automated

AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto

Other group

Description:

Lotrafilcon B contact lens with color, semi-automated, worn first, with Lotrafilcon B contact lens with color, automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.

Treatment:

Device: Lotrafilcon B contact lens with color, automated

Device: Lotrafilcon B contact lens with color, semi-automated