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 for soft contact lenses in patients who experience discomfort with their contact lenses.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Symptomatic for contact lens related discomfort at the end of the lens wearing day. * Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks. * Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable). * Successful lens wear for at least 4 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 |
|---|---|
| Efficacy: | — |
| Ocular Comfort and Symptom Scales | — |
| Subject Questions/Subject Likert Questionnaire | — |
| Safety: | — |
| Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications | — |
| Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| Average Lens Wearing Time | — |
| Corneal Fluorescein Staining (Type and Area) | — |
| Average Uncomfortable Lens Wearing Time | — |
| Lens Surface Evaluation (Lens Deposit and Lens Wettability) | — |
| Lens Replacement Incidence and Causality | — |
| Corrected Visual Acuity with Study Lenses (Snellen) | — |
| Rewetting Drop Frequency | — |
| Lens Removal Frequency | — |
Countries
United States