Contact Lens Care
Conditions
Keywords
Contact Lens Care
Brief summary
The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution in patients wearing silicone hydrogel soft contact lenses.
Interventions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Successful daily wear of Night & Day® or Acuvue® Advance™ silicone hydrogel contact for at least two weeks. * Use of AOSEPT® ClearCare™ only as the pre-study care regimen for at least two weeks (rewetting drops use is also acceptable). * Successful lens wear for at least 8 hours per day. * Vision correctable to 20/30. * Normal eyes - no current ocular abnormalities that prevent successful contact lens wear. * No corneal surgery within the past 12 months. * No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions. * No over-the-counter or prescription ocular medication. * No enrollment in another clinical study within 30 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corrected Visual Acuity with Study Lenses (Snellen) | — |
| Average Lens Wearing Time | — |
| Average Uncomfortable Lens Wearing Time | — |
| Safety: | — |
| Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications | — |
| Ocular Comfort and Symptom Scales | — |
| Corneal Fluorescein Staining (Type and Area) | — |
| Conjunctival Staining | — |
| Lens Deposits | — |
| Subject Questions/Subject Likert Questionnaire | — |
| Lens Replacement Incidence and Causality | — |
| Adverse Events | — |
Countries
United States
Outcome results
None listed