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.
Interventions
DEVICEFID 107027 Multi-Purpose Disinfecting Solution
Investigational, multi-purpose disinfecting solution intended for use in cleaning, rinsing, conditioning, disinfecting, and storing soft contact lenses.
DEVICEReNu MultiPlus Multi-Purpose Solution No Rub Formula
Commercially marketed product indicated for cleaning, rinsing, disinfecting, and storing soft contact lenses.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Successful daily wear of FDA Group I or IV lenses on a two-week or longer replacement schedule for at least one month. * 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 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.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses | Day 90 |
Secondary
| Measure | Time frame |
|---|---|
| Average Lens Wearing Time | Day 90 |
Countries
United States
Outcome results
None listed