Compliance and Contamination in Soft Contact Lens Wearers

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT01069237
Collaborator
(none)
40
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: OPTI-FREE RepleniSH
  • Device: Clear Care

Detailed Description

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

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Time Perspective:
Prospective
Official Title:
Compliance and Contamination in Soft Contact Lens Wearers
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
OPTI-FREE Replenish

Multi-Purpose Solution for soft contact lenses

Device: OPTI-FREE RepleniSH
Multi-Purpose Solution for soft contact lenses

Clear Care

Lens Care Solution for contact lenses

Device: Clear Care
Lens Care Solution for contact lenses

Outcome Measures

Primary Outcome Measures

  1. Microbial colonization on soft contact lenses and lens cases associated with daily lens wear [2 weeks]

Secondary Outcome Measures

  1. Regimen compliance [Baseline, 2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Successful contact lens wear on a daily wear basis

  • Normal Eyes

Exclusion Criteria:
  • Topical ocular medication use

  • No active ocular issues

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Alcon Research

Investigators

  • Study Director: Jami Kern, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01069237
Other Study ID Numbers:
  • SMA-09-45
First Posted:
Feb 17, 2010
Last Update Posted:
Feb 1, 2012
Last Verified:
Jan 1, 2012
Keywords provided by Alcon Research

Study Results

No Results Posted as of Feb 1, 2012