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

AIR OPTIX® COLORS: Automated vs Semi-automated Manufacturing Processes

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Lotrafilcon B contact lens with color, automated; Device: Lotrafilcon B contact lens with color, semi-automated

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto; 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.	Device: Lotrafilcon B contact lens with color, automated; Silicone hydrogel contact lens with color manufactured via an automated process; Other Names: AIR OPTIX® COLORS; Device: Lotrafilcon B contact lens with color, semi-automated; Silicone hydrogel contact lens with color manufactured via a semi-automated process; Other Names: AIR OPTIX® COLORS
Other: AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto; 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.	Device: Lotrafilcon B contact lens with color, automated; Silicone hydrogel contact lens with color manufactured via an automated process; Other Names: AIR OPTIX® COLORS; Device: Lotrafilcon B contact lens with color, semi-automated; Silicone hydrogel contact lens with color manufactured via a semi-automated process; Other Names: AIR OPTIX® COLORS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall satisfaction	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.	Week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall lens fit	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.	Dispense (Day 0)
Overall lens fit	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.	Week 2
Contact Lens Corrected Visual Acuity (CLCVA)	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.	Dispense (Day 0)
Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA)	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.	Week 2

Collaborators and Investigators

• Sponsor: CIBA VISION
• Investigators: Study Director: Sharon Holden Thomas, O.D., Alcon Research

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: June 5, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P-383-C-005/C-12-026; C-12-026 (Other Identifier: Alcon)