Trial record 2 of 842 for:    color

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014