Vision Disorders
Conditions
Keywords
Contact lens, Cleaning solution
Brief summary
The objective of this study is to evaluate the safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.
Interventions
DEVICEInvestigational Cleaning & Disinfecting Solution
Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
DEVICEClear Care Solution
Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be habitual wearers of one of the protocol specified lenses. * Subjects must habitually use a NON-PEROXIDE lens care product for cleaning, disinfecting and storage of their lenses. * Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand. * Subjects must agree to wear their lenses on a daily wear basis for approximately three months.
Exclusion criteria
* Subjects who currently use a hydrogen peroxide cleaning and disinfecting solution. * Subjects who currently wear Opaque Cosmetic Tint Contact Lenses. * Subjects who have worn polymethylmethacrylate (PMMA) lenses within the last three months. * Subjects with any systemic disease currently affecting ocular health or which in the Investigators opinion may have an effect on ocular health during the course of the study. * Subjects using any systemic or topical medications that will, in the Investigators opinion, affect ocular physiology or lens performance. * Subjects with any Present finding during the slit lamp examination that, in the Investigators judgment, interferes with contact lens wear. * Subjects with any scar or neovascularization within the central 4 mm of the cornea. * Subjects who are allergic to any component in the study care products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With > Grade 2 Slit Lamp Findings | 3 months | Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational Solution Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.
Investigational Cleaning & Disinfecting Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution | 222 |
| Clear Care Solution Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses
Clear Care Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution | 218 |
| Total | 440 |
Baseline characteristics
| Characteristic | Investigational Solution | Clear Care Solution | Total |
|---|---|---|---|
| Age, Continuous | 35.4 years | 35.3 years | 35.4 years |
| Sex: Female, Male Female | 160 Participants | 163 Participants | 323 Participants |
| Sex: Female, Male Male | 62 Participants | 55 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 224 | 0 / 220 |
| serious Total, serious adverse events | 0 / 224 | 0 / 220 |
Outcome results
Primary
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities.
Time frame: 3 months
Population: There were 442 dispensed eyes with nonmissing scores in the investigational group and 438 dispensed eyes with nonmissing scores in the Clear Care group.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Investigational Solution | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 4 eyes |
| Clear Care Solution | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 0 eyes |