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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614678
• Other study ID #: P-383-C-005/C-12-026
• Secondary ID: C-12-026
• Status: Completed
• Phase: N/A
• First received: June 5, 2012
• Last updated: May 3, 2017
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon B contact lens with color, automated
Silicone hydrogel contact lens with color manufactured via an automated process
• Lotrafilcon B contact lens with color, semi-automated
Silicone hydrogel contact lens with color manufactured via a semi-automated process

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	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