Contact Lens Solutions
Conditions
Keywords
Efficacy
Brief summary
This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.
Interventions
Daily care for contact lenses.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis. * Must be able and willing to comply with all treatment and follow-up study procedures. * Must have a clear central cornea. * VA correctable to 0.3 LogMar or better (driving vision)
Exclusion criteria
* Systemic disease affecting ocular health. * Using systemic or topical medications. * Wear monovision, multifocal or toric contact lenses. * Any grade 2 or greater slit lamp findings. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobial Efficacy | 2 weeks, 3 months | Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Solution Related AE's and Lens Changes | 3 months, 6 months | Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued. |
| Solution Utlility | 3 months, 6 months | The Utility was determined based on the results of the efficacy and safety evaluations. |
Countries
United States
Participant flow
Recruitment details
First participant was enrolled in this study on 07/07/2008 and last subject exited on 02/02/2009. 180 participants were enrolled at 9 investigative sites in the United States.
Pre-assignment details
This study focused on participants of Japanese descent (at least one grandparent born in Japan) for a minimum of 20% of total enrollment. 180 participants were enrolled, 3 participants were ineligible at screening, 177 participants were eligible at the start of the study.
Participants by arm
| Arm | Count |
|---|---|
| Multi-purpose Solution and Optima 38 Lenses Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months. | 60 |
| Multi-Purpose Solution and Acuvue 2 Lenses B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months. | 117 |
| Total | 177 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 3 |
Baseline characteristics
| Characteristic | Multi-purpose Solution and Optima 38 Lenses | Multi-Purpose Solution and Acuvue 2 Lenses | Total |
|---|---|---|---|
| Age, Customized Aged 18-64 | 60 Participants 11 | 117 Participants 10.3 | 177 Participants |
| Participants with Grandparents Born in Japan 1 Grandparent | 0 Participants | 11 Participants | 11 Participants |
| Participants with Grandparents Born in Japan 2 Grandparents | 7 Participants | 18 Participants | 25 Participants |
| Participants with Grandparents Born in Japan 3 Grandparents | 4 Participants | 6 Participants | 10 Participants |
| Participants with Grandparents Born in Japan 4 Grandparents | 49 Participants | 82 Participants | 131 Participants |
| Sex: Female, Male Female | 37 Participants | 75 Participants | 112 Participants |
| Sex: Female, Male Male | 23 Participants | 42 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 120 | 0 / 240 |
| serious Total, serious adverse events | 0 / 120 | 0 / 240 |
Outcome results
Primary
Antimicrobial Efficacy
Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae
Time frame: 2 weeks, 3 months
Population: All eligible, dispensed eyes with cultures taken within window. Group I subjects were cultured at the 3-Month Visit. Group IV subjects were cultured at the 2-week Follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Multi-purpose Solution and Optima 38 Lenses | Antimicrobial Efficacy | Good | 0 Eyes |
| Multi-purpose Solution and Optima 38 Lenses | Antimicrobial Efficacy | Skeptical | 1 Eyes |
| Multi-purpose Solution and Optima 38 Lenses | Antimicrobial Efficacy | Excellent | 114 Eyes |
| Multi-purpose Solution and Optima 38 Lenses | Antimicrobial Efficacy | No Efficacy | 0 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Antimicrobial Efficacy | No Efficacy | 0 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Antimicrobial Efficacy | Good | 3 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Antimicrobial Efficacy | Excellent | 219 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Antimicrobial Efficacy | Skeptical | 4 Eyes |
Secondary
Solution Related AE's and Lens Changes
Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.
Time frame: 3 months, 6 months
Population: All Eligible, Dispensed Eyes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Multi-purpose Solution and Optima 38 Lenses | Solution Related AE's and Lens Changes | Not Safe | 0 Eyes |
| Multi-purpose Solution and Optima 38 Lenses | Solution Related AE's and Lens Changes | Skeptical | 0 Eyes |
| Multi-purpose Solution and Optima 38 Lenses | Solution Related AE's and Lens Changes | Safe | 2 Eyes |
| Multi-purpose Solution and Optima 38 Lenses | Solution Related AE's and Lens Changes | Very Safe | 118 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Solution Related AE's and Lens Changes | Not Safe | 0 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Solution Related AE's and Lens Changes | Very Safe | 238 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Solution Related AE's and Lens Changes | Safe | 2 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Solution Related AE's and Lens Changes | Skeptical | 0 Eyes |
Secondary
Solution Utlility
The Utility was determined based on the results of the efficacy and safety evaluations.
Time frame: 3 months, 6 months
Population: All Eligible, Dispensed Eyes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Multi-purpose Solution and Optima 38 Lenses | Solution Utlility | Very Useful | 112 Eyes |
| Multi-purpose Solution and Optima 38 Lenses | Solution Utlility | Useful | 2 Eyes |
| Multi-purpose Solution and Optima 38 Lenses | Solution Utlility | Slightly Useful | 1 Eyes |
| Multi-purpose Solution and Optima 38 Lenses | Solution Utlility | Not Useful | 0 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Solution Utlility | Useful | 5 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Solution Utlility | Slightly Useful | 4 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Solution Utlility | Not Useful | 0 Eyes |
| Multi-Purpose Solution and Acuvue 2 Lenses | Solution Utlility | Very Useful | 225 Eyes |