Trial Outcomes & Findings for Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops (NCT NCT00756093)
NCT ID: NCT00756093
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, Then Optive, Then Blink Tears, Then GenTeal Moderate
Pateints received Systane first, then Optive, then Blink Tears, then GenTeal Moderate last.
|
Optive, Then Blink Tears, Then GenTeal Moderate, Then Systane
Patients received Optive first, then Blink Tears, then GenTeal Moderate, then Systane
|
Blink Tears, Then GenTeal Moderate, Then Systane, Then Optive
Patients received Blink Tears first, then GenTeal Moderate, then Systane, then Optive last
|
GenTeal Moderate, Then Systane, Then Optive, Then Blink Tears
Patients received GenTeal Moderate first, then Systane, then Optive, then Blink Tears last
|
|---|---|---|---|---|
|
First Intervention
STARTED
|
5
|
5
|
5
|
5
|
|
First Intervention
COMPLETED
|
5
|
5
|
5
|
5
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
5
|
5
|
5
|
5
|
|
Second Intervention
COMPLETED
|
5
|
5
|
5
|
5
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
5
|
5
|
5
|
5
|
|
Third Intervention
COMPLETED
|
5
|
5
|
5
|
5
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Fourth Intervention
STARTED
|
5
|
5
|
5
|
5
|
|
Fourth Intervention
COMPLETED
|
5
|
5
|
5
|
5
|
|
Fourth Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops
Baseline characteristics by cohort
| Measure |
Overall Study
n=20 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 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 Lubricant Eye Drops
n=20 Participants
Systane Ultra Lubricant Eye Drops
|
Optive Lubricant Eye Drops
n=20 Participants
Optive Lubricant Eye Drops
|
Blink Tears
n=20 Participants
Blink Tears
|
GenTeal Moderate Lubricant Eye Drops
n=20 Participants
GenTeal Moderate Lubricant Eye Drops
|
|---|---|---|---|---|
|
Drop Comfort
|
0.7 units on a scale
Standard Deviation 1.26
|
1.05 units on a scale
Standard Deviation 1.10
|
1.84 units on a scale
Standard Deviation 2.19
|
1.1 units on a scale
Standard Deviation 1.21
|
Adverse Events
Systane Ultra Lubricant Eye Drops
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Optive Lubricant Eye Drops
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Blink Tears
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GenTeal Moderate Lubricant Eye Drops
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