NCT01782482

Brief Summary

The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
574

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

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

First Submitted

Initial submission to the registry

January 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 28, 2014

Completed
Last Updated

May 9, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

January 31, 2013

Results QC Date

February 18, 2014

Last Update Submit

April 25, 2014

Conditions

MyopiaRefractive Error

Keywords

Color contact lensesRefractive errorMyopia

Outcome Measures

Primary Outcomes (1)

  • Subjective Rating of Overall Satisfaction

    Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating.

    Day 7

Secondary Outcomes (1)

  • Positive Purchase Intent

    Day 7

Study Arms (2)

AIR OPTIX® COLORS

EXPERIMENTAL

Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.

Device: Lotrafilcon B contact lens with color

FRESHLOOK® COLORBLENDS

ACTIVE COMPARATOR

Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.

Device: Phemfilcon A contact lens with color

Interventions

Lotrafilcon B contact lens with colorDEVICE

Silicone hydrogel contact lens with color

Also known as: AIR OPTIX® COLORS
AIR OPTIX® COLORS
Phemfilcon A contact lens with colorDEVICE

Hydrogel contact lens with color

Also known as: FRESHLOOK® COLORBLENDS
FRESHLOOK® COLORBLENDS

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document.
  • Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance.
  • Manifest cylinder less than or equal to 0.75 diopter in each eye.
  • Wear contact lenses within protocol-defined specifications.
  • Require spherical contact lenses within the available range of powers.

You may not qualify if:

  • Any eye condition that contraindicates contact lens wear.
  • Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • Moderate or severe ocular findings upon examination.
  • Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops.
  • Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
  • Previous corneal or refractive surgery or irregular cornea.
  • Eye injury or surgery within the last 6 months (excluding placement of punctal plugs).
  • Monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
  • History of intolerance or hypersensitivity to any component of the test articles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MyopiaRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Sharon Thomas, O.D., Sr. Principal Clinical Scientist
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Sharon Holden Thomas, O.D.

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 4, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 9, 2014

Results First Posted

March 28, 2014

Record last verified: 2014-03