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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01614678
First received: June 5, 2012
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: AIR OPTIX® COLORS: Automated vs Semi-automated Manufacturing Processes

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Overall satisfaction [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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:
  • Overall lens fit [ Time Frame: Dispense (Day 0) ] [ Designated as safety issue: No ]
    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.

  • Overall lens fit [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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.

  • Contact Lens Corrected Visual Acuity (CLCVA) [ Time Frame: Dispense (Day 0) ] [ Designated as safety issue: No ]
    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.

  • Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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.


Enrollment: 49
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: AIR OPTIX® COLORS
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 Name: 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 Name: AIR OPTIX® COLORS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614678

Sponsors and Collaborators
CIBA VISION
Investigators
Study Director: Sharon Holden Thomas, O.D. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01614678     History of Changes
Other Study ID Numbers: P-383-C-005/C-12-026, C-12-026
Study First Received: June 5, 2012
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
myopia

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014