NCT00381446

Brief Summary

The purpose of this study is to quantify the amount of corneal staining observed with various marketed contact lens/multipurpose solution combinations. The hypothesis is that there are measurable differences in the amount of corneal staining between the various combinations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 27, 2007

Status Verified

September 1, 2007

First QC Date

September 25, 2006

Last Update Submit

September 26, 2007

Conditions

Corneal Epithelial DisruptionCorneal Staining

Keywords

corneal stainingcontact lens caremultipurpose solution

Outcome Measures

Primary Outcomes (1)

  • Area of Corneal Staining

Secondary Outcomes (1)

  • Type (severity) of Corneal Staining

Interventions

Marketed contact lens care productsDEVICE

Eligibility Criteria

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

You may qualify if:

  • currently wearing soft contact lenses daily wear for at least 2 weeks prior to study
  • correct visual acuity of 20/30 or better each eye

You may not qualify if:

  • history of hypersensitivity to any components of solution being tested
  • any ocular condition prohibiting contact lens wear
  • excessive baseline staining as defined in protocol
  • use of topical or OTC ocular medications during the study
  • seasonal allergies with significant effect on contact lens wear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Richard Erdey office

Columbus, Ohio, 43213, United States

RECRUITING

Study Officials

  • Gary J. Andrasko, OD, MS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary J. Andrasko, OD, MS

CONTACT

614-459-3363gandrask@columbus.rr.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 27, 2006

Study Start

July 1, 2005

Study Completion

March 1, 2008

Last Updated

September 27, 2007

Record last verified: 2007-09

Locations

US(1)