NCT00407238

Brief Summary

The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

October 23, 2007

Status Verified

October 1, 2007

First QC Date

November 17, 2006

Last Update Submit

October 21, 2007

Conditions

Contact Lens Care

Keywords

barrier function, multi-purpose solutions, silicone hydrogel contact lenses

Outcome Measures

Primary Outcomes (1)

  • Ratio of fluorescein dye penetration rate of test eye vs. control

Secondary Outcomes (1)

  • Corneal fluorescein staining

Interventions

Multi-purpose solutions (polyquaternium-1 and PHMB)DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adapted daily soft contact lens wearers, at least 18 years of age, vision correctable to 20/40

You may not qualify if:

  • Ocular or systemic allergies, abnormalities of the cornea, active ocular infection, prior keratorefractive surgery, use of ocular medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

Study Officials

  • Jerry R Paugh, OD, PhD

    Southern California College of Optometry at Marshall B. Ketchum University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2006

First Posted

December 4, 2006

Study Start

November 1, 2006

Study Completion

March 1, 2007

Last Updated

October 23, 2007

Record last verified: 2007-10

Locations

US(1)