Trial Outcomes & Findings for Evaluation of a Multi-Purpose Solution (NCT NCT00710879)
NCT ID: NCT00710879
Last Updated: 2011-12-13
Results Overview
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
COMPLETED
NA
180 participants
2 weeks, 3 months
2011-12-13
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
117
|
|
Overall Study
COMPLETED
|
58
|
113
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
3
|
Baseline Characteristics
Evaluation of a Multi-Purpose Solution
Baseline characteristics by cohort
| Measure |
Multi-purpose Solution and Optima 38 Lenses
n=60 Participants
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.
|
Multi-Purpose Solution and Acuvue 2 Lenses
n=117 Participants
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.
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Aged 18-64
|
60 Participants
11.0 • n=93 Participants
|
117 Participants
10.3 • n=4 Participants
|
177 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Participants with Grandparents Born in Japan
1 Grandparent
|
0 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Participants with Grandparents Born in Japan
2 Grandparents
|
7 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Participants with Grandparents Born in Japan
3 Grandparents
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Participants with Grandparents Born in Japan
4 Grandparents
|
49 Participants
n=93 Participants
|
82 Participants
n=4 Participants
|
131 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 weeks, 3 monthsPopulation: 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.
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
Outcome measures
| Measure |
Multi-purpose Solution and Optima 38 Lenses
n=115 eyes
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.
|
Multi-Purpose Solution and Acuvue 2 Lenses
n=226 eyes
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.
|
|---|---|---|
|
Antimicrobial Efficacy
Excellent
|
114 Eyes
|
219 Eyes
|
|
Antimicrobial Efficacy
Good
|
0 Eyes
|
3 Eyes
|
|
Antimicrobial Efficacy
Skeptical
|
1 Eyes
|
4 Eyes
|
|
Antimicrobial Efficacy
No Efficacy
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: All Eligible, Dispensed Eyes
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.
Outcome measures
| Measure |
Multi-purpose Solution and Optima 38 Lenses
n=120 eyes
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.
|
Multi-Purpose Solution and Acuvue 2 Lenses
n=240 eyes
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.
|
|---|---|---|
|
Solution Related AE's and Lens Changes
Not Safe
|
0 Eyes
|
0 Eyes
|
|
Solution Related AE's and Lens Changes
Very Safe
|
118 Eyes
|
238 Eyes
|
|
Solution Related AE's and Lens Changes
Safe
|
2 Eyes
|
2 Eyes
|
|
Solution Related AE's and Lens Changes
Skeptical
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: All Eligible, Dispensed Eyes
The Utility was determined based on the results of the efficacy and safety evaluations.
Outcome measures
| Measure |
Multi-purpose Solution and Optima 38 Lenses
n=115 Eyes
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.
|
Multi-Purpose Solution and Acuvue 2 Lenses
n=234 Eyes
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.
|
|---|---|---|
|
Solution Utlility
Very Useful
|
112 Eyes
|
225 Eyes
|
|
Solution Utlility
Useful
|
2 Eyes
|
5 Eyes
|
|
Solution Utlility
Slightly Useful
|
1 Eyes
|
4 Eyes
|
|
Solution Utlility
Not Useful
|
0 Eyes
|
0 Eyes
|
Adverse Events
Multi-purpose Solution and Optima 38 Lenses
Multi-Purpose Solution and Acuvue 2 Lenses
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER