Trial Outcomes & Findings for Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution (NCT NCT01341977)
NCT ID: NCT01341977
Last Updated: 2020-09-23
Results Overview
Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
573 participants
Primary outcome timeframe
Day 90
Results posted on
2020-09-23
Participant Flow
Participant milestones
| Measure |
Alcon MPDS
Alcon Multi-Purpose Disinfecting Solution (MPDS)
|
ReNu Fresh Multi-Purpose Solution
ReNu Fresh Multi-Purpose Solution (MPS)
|
|---|---|---|
|
Overall Study
STARTED
|
288
|
285
|
|
Overall Study
COMPLETED
|
274
|
270
|
|
Overall Study
NOT COMPLETED
|
14
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution
Baseline characteristics by cohort
| Measure |
Alcon MPDS
n=288 Participants
Alcon Multi-Purpose Disinfecting Solution (MPDS)
|
ReNu Fresh Multi-Purpose Solution
n=285 Participants
ReNu Fresh Multi-Purpose Solution (MPS)
|
Total
n=573 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
279 Participants
n=99 Participants
|
257 Participants
n=107 Participants
|
536 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
33.9 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
33.9 years
STANDARD_DEVIATION 11.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
214 Participants
n=99 Participants
|
197 Participants
n=107 Participants
|
411 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
162 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
288 participants
n=99 Participants
|
285 participants
n=107 Participants
|
573 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 90Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)
Outcome measures
| Measure |
Alcon MPDS
n=288 Participants
Alcon Multi-Purpose Disinfecting Solution (MPDS)
|
ReNu Fresh Multi-Purpose Solution
n=285 Participants
ReNu Fresh Multi-Purpose Solution (MPS)
|
|---|---|---|
|
Subjective Acceptance
|
1.9 units on a scale
Standard Deviation .8
|
2.1 units on a scale
Standard Deviation 1.0
|
Adverse Events
Alcon MPDS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ReNu Fresh Multi-Purpose Solution
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alcon MPDS
n=288 participants at risk
Alcon Multi-Purpose Disinfecting Solution (MPDS)
|
ReNu Fresh Multi-Purpose Solution
n=285 participants at risk
ReNu Fresh Multi-Purpose Solution (MPS)
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/288 • AE Forms document adverse events during study(occurring after exposure to test article), causality assessment performed by investigator/sponsor. A SAE Form completed & forwarded to Alcon/IRB/EC 24 hours of investigator's knowledge of event
AE Forms document all AEs that occur during study (occurring after exposure to test article), causality assessment performed by investigator/sponsor. A SAE Form completed for all SAEs, forwarded to Alcon/IRB/EC within 24 hours of the investigator's knowledge of the event according to their requirements.
|
0.35%
1/285 • Number of events 1 • AE Forms document adverse events during study(occurring after exposure to test article), causality assessment performed by investigator/sponsor. A SAE Form completed & forwarded to Alcon/IRB/EC 24 hours of investigator's knowledge of event
AE Forms document all AEs that occur during study (occurring after exposure to test article), causality assessment performed by investigator/sponsor. A SAE Form completed for all SAEs, forwarded to Alcon/IRB/EC within 24 hours of the investigator's knowledge of the event according to their requirements.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data and discoveries arising out of the Study shall be the sole property of Alcon or its designated affiliate. Alcon reserves the right of prior review of any publication or presentation of the information related to the Study.
- Publication restrictions are in place
Restriction type: OTHER