Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
Shorter than P25 for not_applicable
1 active site
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
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 7, 2010
CompletedFirst Posted
Study publicly available on registry
April 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedOctober 23, 2012
July 1, 2012
6 months
April 7, 2010
October 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tear Protein Expression
1 day
Secondary Outcomes (1)
Corneal Staining
1 day
Study Arms (2)
Contact lens wearers
EXPERIMENTALContact 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.
Non-lens wearers
NO INTERVENTIONNon-lens wearers completed one study visit and served as the control group.
Interventions
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
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.
Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Eligibility Criteria
You may qualify if:
- 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).
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134, United States
Study Officials
- STUDY DIRECTOR
Jami Kern
Alcon, Ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2010
First Posted
April 9, 2010
Study Start
March 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
October 23, 2012
Record last verified: 2012-07