NCT01440322

Brief Summary

The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

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

September 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 28, 2014

Completed
Last Updated

May 8, 2014

Status Verified

April 1, 2014

Enrollment Period

4 months

First QC Date

September 22, 2011

Results QC Date

February 18, 2014

Last Update Submit

April 24, 2014

Conditions

Refractive Error

Keywords

MyopiaContact lenses

Outcome Measures

Primary Outcomes (1)

  • Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)

    Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.

    Up to Month 3

Secondary Outcomes (8)

  • Subjective Rating of Overall Vision

    Up to Month 3

  • Subjective Rating of Overall Comfort

    Up to Month 3

  • Subjective Rating of Overall Handling

    Up to Month 3

  • Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)

    Up to Month 3

  • Lens Centration (Centered, Slight Decentration)

    Up to Month 3

  • +3 more secondary outcomes

Study Arms (2)

AIR OPTIX® COLORS

EXPERIMENTAL

Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months

Device: Lotrafilcon B contact lens with color

AIR OPTIX® AQUA

ACTIVE COMPARATOR

Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months

Device: Lotrafilcon B contact lens

Interventions

Lotrafilcon B contact lens with colorDEVICE

Silicone hydrogel contact lens with color

Also known as: AIR OPTIX® COLORS
AIR OPTIX® COLORS
Lotrafilcon B contact lensDEVICE

Silicone hydrogel contact lens

Also known as: AIR OPTIX® AQUA
AIR OPTIX® AQUA

Eligibility Criteria

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

You may qualify if:

  • Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
  • Normal eyes and not using any ocular medications.
  • Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
  • Manifest cylinder less than or equal to 0.75 diopter.
  • Best spectacle corrected visual acuity greater than or equal to 20/25.
  • Have current prescription glasses.

You may not qualify if:

  • Anterior segment infection, inflammation, or abnormality.
  • Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
  • Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
  • History of refractive surgery or irregular cornea.
  • History of pathologically dry eye.
  • Corneal vascularization greater than 1 millimeter of penetration.
  • History of herpetic keratitis.
  • Eye injury within 12 weeks immediately prior to enrollment in this trial.
  • Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Refractive ErrorsMyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

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

Study Officials

  • Sharon Holden Thomas, OD

    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
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2011

First Posted

September 26, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 8, 2014

Results First Posted

March 28, 2014

Record last verified: 2014-04