Trial Outcomes & Findings for Evaluation of an Investigational Multi-Purpose Solution (MPS) (NCT NCT00961051)
NCT ID: NCT00961051
Last Updated: 2014-01-07
Results Overview
Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).
COMPLETED
PHASE3
270 participants
Day 30
2014-01-07
Participant Flow
Subjects for this study were chosen from the normal hydrogel contact lens-wearing patient populations at each of the investigational sites according to the following inclusion and exclusion criteria.
Participant milestones
| Measure |
Investigational MPS
Investigational multipurpose disinfecting solution (study MPS)
|
Predicate MPS
Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
|
|---|---|---|
|
Overall Study
STARTED
|
177
|
93
|
|
Overall Study
COMPLETED
|
165
|
79
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of an Investigational Multi-Purpose Solution (MPS)
Baseline characteristics by cohort
| Measure |
Investigational MPS
n=177 Participants
Investigational multipurpose disinfecting solution (study MPS)
|
Predicate MPS
n=93 Participants
Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
177 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
177 participants
n=5 Participants
|
93 participants
n=7 Participants
|
270 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: Lens cleanliness analysis could only be done on subjects whose lenses were returned for analysis. Out of 270 subjects, 253 returned their study lenses to the sponsor for lab analysis (169 + 84 = 253).
Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).
Outcome measures
| Measure |
Investigational MPS
n=169 Participants
Investigational multipurpose disinfecting solution (study MPS)
|
Predicate MPS
n=84 Participants
Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
|
|---|---|---|
|
Mean Lens Cleanliness as Measured by Light Reflectance
|
65.5 light reflectance score
Standard Deviation 13.92
|
66.8 light reflectance score
Standard Deviation 14.95
|
SECONDARY outcome
Timeframe: Day 180Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.
Outcome measures
| Measure |
Investigational MPS
n=165 Participants
Investigational multipurpose disinfecting solution (study MPS)
|
Predicate MPS
n=79 Participants
Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
|
|---|---|---|
|
Number of Subjects With no Corneal Staining
|
129 participants
|
64 participants
|
Adverse Events
Investigational MPS
Predicate MPS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Investigational MPS
n=177 participants at risk
Investigational multipurpose disinfecting solution (study MPS)
|
Predicate MPS
n=93 participants at risk
Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
|
|---|---|---|
|
Eye disorders
Red eye
|
0.56%
1/177 • Number of events 1
|
2.2%
2/93 • Number of events 2
|
|
Eye disorders
Conjunctivitis
|
1.1%
2/177 • Number of events 2
|
1.1%
1/93 • Number of events 1
|
|
Eye disorders
Corneal infiltrates
|
0.56%
1/177 • Number of events 1
|
0.00%
0/93
|
|
Eye disorders
Corneal ulcer
|
0.56%
1/177 • Number of events 1
|
0.00%
0/93
|
|
Eye disorders
Foreign body sensation
|
0.56%
1/177 • Number of events 1
|
0.00%
0/93
|
|
Eye disorders
Seasonal eye allergies
|
0.00%
0/177
|
2.2%
2/93 • Number of events 2
|
|
Eye disorders
Keratitis
|
0.00%
0/177
|
1.1%
1/93 • Number of events 1
|
|
Eye disorders
Superficial punctate keratopathy
|
0.00%
0/177
|
1.1%
1/93 • Number of events 1
|
|
Eye disorders
Giant papillary conjunctivitis
|
0.00%
0/177
|
1.1%
1/93 • Number of events 1
|
|
Eye disorders
Recurrent corneal erosion
|
0.00%
0/177
|
1.1%
1/93 • Number of events 1
|
|
Eye disorders
Hypersensitivity to study solution
|
0.00%
0/177
|
2.2%
2/93 • Number of events 2
|
|
Eye disorders
Hordeolum
|
0.00%
0/177
|
1.1%
1/93 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to publication release and can embargo communications regarding trials results for a period that is more than 90 days but less than or equal to 18 months from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER