NCT01185834

Brief Summary

The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

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

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 24, 2012

Completed
Last Updated

July 10, 2012

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

August 18, 2010

Results QC Date

December 20, 2011

Last Update Submit

June 26, 2012

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Overall Comfort

    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

    3 months of wear, replacing lenses monthly

Secondary Outcomes (1)

  • Overall Lens Fit

    3 months of wear, replacing lenses monthly

Interventions

Lotrafilcon A upgrade soft contact lensDEVICE

Silicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights.

Eligibility Criteria

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

You may qualify if:

  • Have normal ocular findings.
  • Be able to wear the study lenses in the available powers.
  • Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
  • Wear Night \& Day contact lenses.

You may not qualify if:

  • Require concurrent ocular medication.
  • Eye injury or surgery within twelve weeks prior to enrollment.
  • Currently enrolled in an ophthalmic clinical trial.
  • Any active corneal infection.
  • Corneal refractive surgery.
  • Wear AIR OPTIX NIGHT \& DAY AQUA lenses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Sameena Haque-Khan, PhD, BSc(Hons)Optom, MCOptom, FAAO
Organization
Alcon Research, Ltd.
1-800-241-7629

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 20, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 10, 2012

Results First Posted

January 24, 2012

Record last verified: 2011-12