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

Corneal Staining Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100424
• Other study ID #: SMA-09-20
• Status: Completed
• Phase: N/A
• First received: April 7, 2010
• Last updated: October 19, 2012
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: July 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Corneal Staining

Intervention

Device:
• Opti-Free RepleniSH
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
• ReNu MultiPlus
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
• 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:
• Unisol 4
Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Protein Expression		1 day	No
Secondary	Corneal Staining		1 day	Yes