Trial Outcomes & Findings for Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens (NCT NCT02258139)
NCT ID: NCT02258139
Last Updated: 2020-09-14
Results Overview
Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
8 hours
Results posted on
2020-09-14
Participant Flow
Participant milestones
| Measure |
Study Group 1
1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B\&L Investigational Contact Lens
B\&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Baseline characteristics by cohort
| Measure |
Study Group 1
n=38 Participants
1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B\&L Investigational Contact Lens
B\&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.
|
|---|---|
|
Age, Continuous
|
21.4 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hoursPercent change in central corneal thickness from evening to morning (after 8 hours with lid closed)
Outcome measures
| Measure |
Study Group 1
n=38 Participants
1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B\&L Investigational Contact Lens
B\&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.
|
Control Eye
Control eye in subjects with lens in test eye
|
|---|---|---|
|
Percent Change in Central Corneal Thickness
Visit 1 (without lens)
|
4.01 milimeters
Standard Deviation 1.57
|
—
|
|
Percent Change in Central Corneal Thickness
Visit 2 (with lens)
|
5.57 milimeters
Standard Deviation 2.11
|
—
|
SECONDARY outcome
Timeframe: 48 hoursTime (hours) to restore central corneal thickness to its baseline value after lens removal
Outcome measures
| Measure |
Study Group 1
n=38 Participants
1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B\&L Investigational Contact Lens
B\&L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.
|
Control Eye
n=38 Participants
Control eye in subjects with lens in test eye
|
|---|---|---|
|
Time to Restore Central Corneal Thickness
2 hours
|
44.7 percentage of participants
|
23.7 percentage of participants
|
|
Time to Restore Central Corneal Thickness
0 hours
|
0 percentage of participants
|
5.3 percentage of participants
|
|
Time to Restore Central Corneal Thickness
1 hours
|
34.2 percentage of participants
|
63.2 percentage of participants
|
|
Time to Restore Central Corneal Thickness
3 hours
|
15.8 percentage of participants
|
5.3 percentage of participants
|
|
Time to Restore Central Corneal Thickness
4 hours
|
5.3 percentage of participants
|
2.6 percentage of participants
|
|
Time to Restore Central Corneal Thickness
>4 hours
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Study Group 1
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 Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER