Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Solution | Experimental | Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses. |
|
| Clear Care Solution | Active Comparator | Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Cleaning & Disinfecting Solution | Device | Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Beverly Barna | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Rochester | New York | 14609 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographics are reported for all eligible, dispensed subjects; 222 in the investigational group and 218 in the Clear Care group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Clear Care Solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | There were 442 dispensed eyes with nonmissing scores in the investigational group and 438 dispensed eyes with nonmissing scores in the Clear Care group. | Posted | Count of Units | eyes | 3 months | eyes | eyes |
|
3 months
Adverse events were not coded. Therefore, source vocabulary is not applicable. There were 448 eyes dispensed investigational solution and 440 eyes dispensed control solution, assessed for adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 585-338-6399 | robert.steffen@bausch.com |
Not provided
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clear Care Solution | Device | Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| 0 |
| 224 |
| 0 |
| 224 |
| EG001 | 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 | 0 | 220 | 0 | 220 |
Contact sponsor directly for details.
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |