Trial Outcomes & Findings for Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses (NCT NCT01548833)
NCT ID: NCT01548833
Last Updated: 2013-06-24
Results Overview
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.
COMPLETED
NA
39 participants
Day 7, 16 hours after lens insertion
2013-06-24
Participant Flow
Participants were recruited from one study center in the United Kingdom.
This reporting group includes all enrolled participants.
Participant milestones
| Measure |
Overall
All enrolled participants
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses
Baseline characteristics by cohort
| Measure |
Overall
n=39 Participants
DT1, TruEye, and Clariti contact lenses worn in randomized, cross-over fashion for one week each
|
|---|---|
|
Age Continuous
|
22.1 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7, 16 hours after lens insertionThe pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.
Outcome measures
| Measure |
Dailies Total 1
n=39 Participants
Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
|
TruEye
n=39 Participants
Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
|
Clariti
n=39 Participants
Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
|
|---|---|---|---|
|
Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)
|
13.56 seconds
Standard Deviation 3.7759121
|
12.0 seconds
Standard Deviation 2.9676727
|
11.86 seconds
Standard Deviation 3.5982819
|
Adverse Events
Dailies Total 1
TruEye
Clariti
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 Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER