NCT01614678

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 5, 2017

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

June 5, 2012

Last Update Submit

May 3, 2017

Conditions

Myopia

Keywords

myopia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Overall lens fit

    Dispense (Day 0)

  • Overall lens fit

    Week 2

  • Contact Lens Corrected Visual Acuity (CLCVA)

    Dispense (Day 0)

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

    Week 2

Study Arms (2)

AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto

OTHER

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, automatedDevice: Lotrafilcon B contact lens with color, semi-automated

AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto

OTHER

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, automatedDevice: Lotrafilcon B contact lens with color, semi-automated

Interventions

Lotrafilcon B contact lens with color, automatedDEVICE

Silicone hydrogel contact lens with color manufactured via an automated process

Also known as: AIR OPTIX® COLORS
AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-autoAIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto
Lotrafilcon B contact lens with color, semi-automatedDEVICE

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

Also known as: AIR OPTIX® COLORS
AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-autoAIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Sharon Holden Thomas, O.D.

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 8, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 5, 2017

Record last verified: 2014-02