Trial Outcomes & Findings for Acute Comfort and Blur of Systane Ultra and Systane (NCT NCT00748865)
NCT ID: NCT00748865
Last Updated: 2012-02-02
Results Overview
Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
once upon instillation
Results posted on
2012-02-02
Participant Flow
20 dry eye subjects
Randomized, double-masked, cross-over design
Participant milestones
| Measure |
Systane Ultra Drops, Then Systane Drops
Patients received Systane Ultra Drops first, then received Systane Drops.
|
Systane Drops, Then Systane Ultra Drops
Patients first received Systane Drops, then received Systane Ultra Drops
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Comfort and Blur of Systane Ultra and Systane
Baseline characteristics by cohort
| Measure |
Overall Study
n=20 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: once upon instillationDrop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,
Outcome measures
| Measure |
Systane Ultra
n=20 Participants
Systane Ultra
|
Systane
n=20 Participants
Systane
|
|---|---|---|
|
Drop Comfort
|
0.55 Units on a scale
Standard Deviation 0.69
|
0.60 Units on a scale
Standard Deviation 0.68
|
Adverse Events
Systane Ultra
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Systane
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 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