Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining

October 19, 2012 updated by: Alcon Research
The purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

For non-lens wearers:

  • Normal eyes.
  • Currently not wearing contact lenses and has not worn contact lenses for the previous 6 months.
  • Free of dry eye using the Ocular Surface Disease Index (Schiffman et al).
  • Other protocol-defined inclusion criteria may apply.

For contact lens wearers:

  • Currently wearing soft contact lenses.
  • Free of dry eye during lens wear using the Contact Lens Dry Eye Questionnaire Short-Form (Nichols et al, Cornea, 2002).
  • Reports a contact lens wearing time of at least 12 hours per day, 7 days per week, daily wear basis (not overnight wear).
  • Reports only occasional use of contact lens rewetting drops or artificial tears.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

For non-lens wearers and contact lens wearers:

  • Pregnant.
  • Participating in another research study.
  • Exhibiting staining with fluorescein in more than 5% of the total cornea (graded by "extent" of staining across 5 regions).
  • Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Contact lens wearers
Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline.
Device: Opti-Free RepleniSH
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Device: ReNu MultiPlus
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Other Names:
  • Renu
Device: Balafilcon A
Commercially available silicone hydrogel contact lenses removed from blister pack and soaked overnight in Opti-Free Replenish, ReNu MultiPlus, or Unisol 4, then applied to the eye and worn for 2 hours.
Other Names:
  • PureVision
Other: Unisol 4
Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
No Intervention: Non-lens wearers
Non-lens wearers completed one study visit and served as the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tear Protein Expression
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Corneal Staining
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Jami Kern, Alcon, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 7, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 9, 2010

Study Record Updates

Last Update Posted (Estimate)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SMA-09-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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