Trial Outcomes & Findings for Acute Comfort of Lubricant Eye Drops FID 112903 (NCT NCT00673855)
NCT ID: NCT00673855
Last Updated: 2012-02-02
Results Overview
Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Three minutes
Results posted on
2012-02-02
Participant Flow
20 Dry Eye Subjects
Randomized, double-masked, crossover
Participant milestones
| Measure |
Lubricant Drops, Then Optive Drops
Patients received lubricant Drops first, then received Optive Drops
|
Optive Drops, Then Lubricant Drops
Patients received Optive Drops first, then received Lubricant Drops
|
|---|---|---|
|
First Intervention
STARTED
|
10
|
10
|
|
First Intervention
COMPLETED
|
10
|
10
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
10
|
|
Second Intervention
COMPLETED
|
10
|
10
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Comfort of Lubricant Eye Drops FID 112903
Baseline characteristics by cohort
| Measure |
Overall Study
n=20 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Three minutesDrop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.
Outcome measures
| Measure |
Lubricant Eye Drops FID 112903
n=20 Participants
Lubricant Eye Drops FID 112903
|
Lubricant Eye Drops
n=20 Participants
Lubricant Eye Drops
|
|---|---|---|
|
Drop Comfort Upon Instillation
|
1.1 Units on a scale
Standard Deviation 1.0
|
1.4 Units on a scale
Standard Deviation 1.6
|
Adverse Events
Lubricant Eye Drops FID 112903
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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.
- Publication restrictions are in place
Restriction type: OTHER