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OpenTrials
Completed

NCT Number: NCT01614678

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lotrafilcon B contact lens with color, automated

Device

Silicone hydrogel contact lens with color manufactured via an automated process

Other names: AIR OPTIX® COLORS

Lotrafilcon B contact lens with color, semi-automated

Device

Silicone hydrogel contact lens with color manufactured via a semi-automated process

Other names: AIR OPTIX® COLORS

Primary outcomes

  1. Overall satisfaction

    Time frame: 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 outcomes

  1. Overall lens fit

    Time frame: Dispense (Day 0)

    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.

  2. Overall lens fit

    Time frame: 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.

  3. Contact Lens Corrected Visual Acuity (CLCVA)

    Time frame: 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.

  4. Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 8, 2012
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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