Corneal Staining
Conditions
Keywords
Contact lenses, Contact lens solution, Corneal staining
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.
Interventions
DEVICEOpti-Free RepleniSH
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
DEVICEReNu MultiPlus
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
DEVICEBalafilcon 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.
OTHERUnisol 4
Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear Protein Expression | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Corneal Staining | 1 day |
Countries
United States
Outcome results
None listed