NCT01069237

Brief Summary

The purpose of this study is to assess the lens and lens case microbial colonization associated with marketed care solutions used by experienced soft lens wearers.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2009

Shorter than P25 for all trials

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

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

February 1, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

February 15, 2010

Last Update Submit

January 30, 2012

Conditions

Contact Lens Wear

Keywords

contact lens wearmulti-purpose solutioncorneal staining

Outcome Measures

Primary Outcomes (1)

  • Microbial colonization on soft contact lenses and lens cases associated with daily lens wear

    2 weeks

Secondary Outcomes (1)

  • Regimen compliance

    Baseline, 2 weeks

Study Arms (2)

OPTI-FREE Replenish

Multi-Purpose Solution for soft contact lenses

Device: OPTI-FREE RepleniSH

Clear Care

Lens Care Solution for contact lenses

Device: Clear Care

Interventions

OPTI-FREE RepleniSHDEVICE

Multi-Purpose Solution for soft contact lenses

OPTI-FREE Replenish
Clear CareDEVICE

Lens Care Solution for contact lenses

Clear Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Contact Lens Wearers

You may qualify if:

  • Successful contact lens wear on a daily wear basis
  • Normal Eyes

You may not qualify if:

  • Topical ocular medication use
  • No active ocular issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jami Kern

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2010

First Posted

February 17, 2010

Study Start

December 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

February 1, 2012

Record last verified: 2012-01