Trial Outcomes & Findings for The Effect of Systane Ultra Lubricant Eye Drops (FID 112903) on Visual Performance (NCT NCT00673764)
NCT ID: NCT00673764
Last Updated: 2012-02-02
Results Overview
Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.
COMPLETED
NA
48 participants
15 minutes, 45 minutes, and 90 minutes post-dose
2012-02-02
Participant Flow
48 Dry Eye Subjects
Randomized, double-masked, crossover
Participant milestones
| Measure |
Systane Ultra, Then Optive
Systane Ultra Lubricant Eye Drops first, then cross-over to Optive.
|
Optive, Then Systane Ultra
Optive Lubricant Eye Drops first, then cross-over to Systane Ultra.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Systane Ultra Lubricant Eye Drops (FID 112903) on Visual Performance
Baseline characteristics by cohort
| Measure |
Overall Study
n=48 Participants
Overall Study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes, 45 minutes, and 90 minutes post-doseMeasuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.
Outcome measures
| Measure |
Systane Ultra
n=48 Participants
Systane Ultra Lubricant Eye Drops.
|
Optive
n=48 Participants
Optive Lubricant Eye Drops
|
|---|---|---|
|
Time at Best Corrected Visual Acuity
45 minutes post-dose
|
6.46 seconds
Standard Error 0.4003
|
5.51 seconds
Standard Error 0.4003
|
|
Time at Best Corrected Visual Acuity
90 minutes post-dose
|
9.17 seconds
Standard Error 0.0365
|
6.84 seconds
Standard Error 0.0365
|
|
Time at Best Corrected Visual Acuity
15 minutes post-dose
|
7.75 seconds
Standard Error 0.6545
|
6.42 seconds
Standard Error .6545
|
SECONDARY outcome
Timeframe: 15 minutes, 45 minutes, and 90 minutes post-doseMeasures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance.
Outcome measures
| Measure |
Systane Ultra
n=48 Participants
Systane Ultra Lubricant Eye Drops.
|
Optive
n=48 Participants
Optive Lubricant Eye Drops
|
|---|---|---|
|
Functional Blink Rate Time (Time Between Blinks)
15 minutes post-dose
|
5.9 seconds
Standard Deviation 5.5
|
5.8 seconds
Standard Deviation 4.7
|
|
Functional Blink Rate Time (Time Between Blinks)
45 minutes post-dose
|
5.9 seconds
Standard Deviation 5.4
|
6.7 seconds
Standard Deviation 4.9
|
|
Functional Blink Rate Time (Time Between Blinks)
90 minutes post-dose
|
6.5 seconds
Standard Deviation 5.8
|
7.3 seconds
Standard Deviation 6.0
|
Adverse Events
Systane Ultra
Optive
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 The PI should hold confidential, and not disclose directly or indirectly to any third party other than Contractors, the data arising out of the study. Alcon 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