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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Lotrafilcon B contact lens with color, automated; Device: Lotrafilcon B contact lens with color, semi-automated

• Registration Number: NCT01614678
• Lead Sponsor: CIBA VISION

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-02
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto	Lotrafilcon B contact lens with color, automated	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.
AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto	Lotrafilcon B contact lens with color, semi-automated	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.
AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto	Lotrafilcon B contact lens with color, semi-automated	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.
AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto	Lotrafilcon B contact lens with color, automated	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.

Primary Outcome Measures

Name	Time	Method
Overall satisfaction	Week 2	The participant was asked, "Please rate your overall satisfaction based on your experience with the study lenses over the last 2 weeks. When considering your rating, please take into account comfort, vision, and handling, but disregard the appearance of the lenses." Overall satisfaction was rated on a scale of 1-10, with 1=Not at all satisfied, and 10=Completely satisfied.

Secondary Outcome Measures

Name	Time	Method
Contact Lens Corrected Visual Acuity (CLCVA)	Dispense (Day 0)	CLCVA (corrected distance monocular visual measurement in normal illumination) was tested for each eye individually while wearing study lenses. Participant read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight.
Overall lens fit	Week 2	Overall lens fit was assessed by the investigator on a 5-point scale, with +2=Unacceptably loose, +1=Acceptably loose, 0=Optimal, -1=Acceptably tight, -2=Unacceptably tight.
Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA)	Week 2	As tested for each eye individually while wearing study lenses. Participant will read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight.