Trial Outcomes & Findings for Corneal and Conjunctival Sensitivity and Staining Study (NCT NCT00455455)
NCT ID: NCT00455455
Last Updated: 2010-07-12
Results Overview
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
COMPLETED
PHASE4
50 participants
baseline
2010-07-12
Participant Flow
Participants recruited from local communities in Kitchener-Waterloo, Canada between May 2007 and Feb 2008.
64 participants recruited and screened; 14 withdrawn prior to the group assignment due to loss of interest, relocation and inconvenience.
Participant milestones
| Measure |
RepleniSH First, Then ReNu
Following a washout period, use RepleniSH for lens care in first period and ReNu in second period (after the second washout period)
|
ReNu First, Then RepleniSH
Following a washout period, use ReNu for lens care in first period and RepleniSH in second period (after the second washout period)
|
|---|---|---|
|
Washout
STARTED
|
25
|
24
|
|
Washout
COMPLETED
|
24
|
24
|
|
Washout
NOT COMPLETED
|
1
|
0
|
|
First Intervention
STARTED
|
25
|
24
|
|
First Intervention
COMPLETED
|
25
|
24
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
24
|
24
|
|
Second Intervention
COMPLETED
|
24
|
24
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
RepleniSH First, Then ReNu
Following a washout period, use RepleniSH for lens care in first period and ReNu in second period (after the second washout period)
|
ReNu First, Then RepleniSH
Following a washout period, use ReNu for lens care in first period and RepleniSH in second period (after the second washout period)
|
|---|---|---|
|
Washout
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Corneal and Conjunctival Sensitivity and Staining Study
Baseline characteristics by cohort
| Measure |
Entire Study Group
n=50 Participants
includes groups randomized to use RepleniSH in the 1st period and ReNu in the 2nd period, and first use ReNu and use RepleniSH in the second period.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age Continuous
|
25 years
STANDARD_DEVIATION 7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
50 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: intent to treat analysis including only participants who had completed the study
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Outcome measures
| Measure |
RepleniSH
n=48 Participants
use RepleniSH for lens care in either first period or second period
|
ReNu
n=48 Participants
Use ReNu for lens care in either first period or second period
|
|---|---|---|
|
Corneal Sensitivity
|
26.9 percent CO2
Standard Deviation 13.0
|
25.5 percent CO2
Standard Deviation 12.9
|
PRIMARY outcome
Timeframe: day 7Population: intent to treat analysis including only participants who had completed the study
The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Outcome measures
| Measure |
RepleniSH
n=48 Participants
use RepleniSH for lens care in either first period or second period
|
ReNu
n=48 Participants
Use ReNu for lens care in either first period or second period
|
|---|---|---|
|
Corneal Sensitivity
|
25.5 percent CO2
Standard Deviation 13.4
|
22.1 percent CO2
Standard Deviation 13.8
|
PRIMARY outcome
Timeframe: baselinePopulation: intent to treat analysis including only participants who had completed the study
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Outcome measures
| Measure |
RepleniSH
n=48 Participants
use RepleniSH for lens care in either first period or second period
|
ReNu
n=48 Participants
Use ReNu for lens care in either first period or second period
|
|---|---|---|
|
Conjunctival Sensitivity
|
48.7 percent CO2
Standard Deviation 20.2
|
49.6 percent CO2
Standard Deviation 18.7
|
PRIMARY outcome
Timeframe: day 7Population: intent to treat analysis including only participants who had completed the study
The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
Outcome measures
| Measure |
RepleniSH
n=48 Participants
use RepleniSH for lens care in either first period or second period
|
ReNu
n=48 Participants
Use ReNu for lens care in either first period or second period
|
|---|---|---|
|
Conjunctival Sensitivity
|
50.5 percent CO2
Standard Deviation 20.2
|
46.2 percent CO2
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: baselinePopulation: intent to treat analysis including only participants who had completed the study
A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).
Outcome measures
| Measure |
RepleniSH
n=48 Participants
use RepleniSH for lens care in either first period or second period
|
ReNu
n=48 Participants
Use ReNu for lens care in either first period or second period
|
|---|---|---|
|
Corneal Staining Grade
|
1.3 units on a scale
Standard Deviation 2.0
|
1.8 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: day 7Population: intent to treat analysis including only participants who had completed the study
A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).
Outcome measures
| Measure |
RepleniSH
n=48 Participants
use RepleniSH for lens care in either first period or second period
|
ReNu
n=48 Participants
Use ReNu for lens care in either first period or second period
|
|---|---|---|
|
Corneal Staining Grade
|
4.7 units on a scale
Standard Deviation 7.5
|
49.9 units on a scale
Standard Deviation 39.9
|
Adverse Events
RepleniSH
ReNu
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