Trial Outcomes & Findings for Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure (NCT NCT00804999)
NCT ID: NCT00804999
Last Updated: 2018-01-23
Results Overview
Looking for cell density
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
baseline and 2 hours
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
Non Contact Wearer Using Clear Care
neutralized Clear Care and no contact lens wear
Clear Care: neutralized Clear Care
|
Overnight Soaking With Renu
ReNu with and without sodium fluorescein
ReNu MultiPlus MPS: overnight soak in solution
|
Overnight Soak in Optifree
RepleniSH with and without sodium fluorescein
ReNu MultiPlus MPS: overnight soak in solution
OPTI-FREE RepleniSH MPDS: overnight soak in solution
|
Overnight Soak in Optifree Replnish
ReNu and RepleniSH
OPTI-FREE RepleniSH MPDS: overnight soak in solution
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
12
|
14
|
10
|
|
Overall Study
COMPLETED
|
15
|
12
|
14
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure
Baseline characteristics by cohort
| Measure |
Non Contact Lens Wearers Using Clear Care
n=15 Participants
neutralized Clear Care and no contact lens wear
Clear Care: neutralized Clear Care
|
Overnight Soaking With Renu
n=12 Participants
ReNu with and without sodium fluorescein
ReNu MultiPlus MPS: overnight soak in solution
|
Overnight Soaking in Optifree
n=14 Participants
RepleniSH with and without sodium fluorescein
ReNu MultiPlus MPS: overnight soak in solution
OPTI-FREE RepleniSH MPDS: overnight soak in solution
|
Overnight Soaking in Optifree Replinish
n=10 Participants
ReNu and RepleniSH
OPTI-FREE RepleniSH MPDS: overnight soak in solution
|
Total
n=51 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline and 2 hoursLooking for cell density
Outcome measures
| Measure |
Non Contact Wearing Using Clear Care
n=15 Participants
neutralized Clear Care and no contact lens wear
Clear Care: neutralized Clear Care
|
Overnight Soaking With Renu
n=12 Participants
ReNu with and without sodium fluorescein
ReNu MultiPlus MPS: overnight soak in solution
|
Overnight Soaking in Optifree
n=14 Participants
RepleniSH with and without sodium fluorescein
ReNu MultiPlus MPS: overnight soak in solution
OPTI-FREE RepleniSH MPDS: overnight soak in solution
|
Overnight Soaking in Optifree Replinish
n=10 Participants
ReNu and RepleniSH
OPTI-FREE RepleniSH MPDS: overnight soak in solution
|
|---|---|---|---|---|
|
HRT Corneal Scan
Baseline
|
85 cells/mm^3
Standard Deviation 112
|
66 cells/mm^3
Standard Deviation 44
|
49 cells/mm^3
Standard Deviation 28
|
63 cells/mm^3
Standard Deviation 081
|
|
HRT Corneal Scan
Two hours
|
87 cells/mm^3
Standard Deviation 110
|
65 cells/mm^3
Standard Deviation 48
|
51 cells/mm^3
Standard Deviation 32
|
61 cells/mm^3
Standard Deviation 77
|
Adverse Events
Non Contact Wearing Using Clear Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Overnight Soaking With Renu
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Overnight Soaking in Optifree
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Overnight Soaking in Optifree Replinish
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
- Publication restrictions are in place