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

Not Applicable

Completed

• Conditions: Corneal Staining
• Interventions: Device: Opti-Free RepleniSH; Device: ReNu MultiPlus; Device: Balafilcon A; Other: Unisol 4

• Registration Number: NCT01100424
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2012-07
• Last Update Submitted: 2012-10-19
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Contact lens wearers	Balafilcon A	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.
Contact lens wearers	Opti-Free RepleniSH	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.
Contact lens wearers	ReNu MultiPlus	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.
Contact lens wearers	Unisol 4	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.

Primary Outcome Measures

Name	Time	Method
Tear Protein Expression	1 day

Secondary Outcome Measures

Name	Time	Method
Corneal Staining	1 day

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States