Trial Outcomes & Findings for Tear Collection in Adult Volunteers (NCT NCT01969162)
NCT ID: NCT01969162
Last Updated: 2014-11-21
Results Overview
Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole).
COMPLETED
35 participants
Day 1
2014-11-21
Participant Flow
Participant milestones
| Measure |
All Participants
Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tear Collection in Adult Volunteers
Baseline characteristics by cohort
| Measure |
All Participants
n=35 Participants
Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
|
|---|---|
|
Age, Continuous
|
23.0 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: A subset of enrolled participants who had non-stimulated (basal) tear samples.
Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole).
Outcome measures
| Measure |
All Participants
n=6 Participants
Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
|
|---|---|
|
Tear Lipid Composition Profile
Cholesterol Ester
|
39.34 pmole
Standard Deviation 6.78
|
|
Tear Lipid Composition Profile
Diacylglycerol
|
0.76 pmole
Standard Deviation 0.49
|
|
Tear Lipid Composition Profile
Free Cholesterol
|
6.58 pmole
Standard Deviation 3.11
|
|
Tear Lipid Composition Profile
Lyso- Phosphatidylcholine
|
1.48 pmole
Standard Deviation 0.71
|
|
Tear Lipid Composition Profile
Lyso- Phosphatidylethanolamine
|
0.74 pmole
Standard Deviation 0.74
|
|
Tear Lipid Composition Profile
Phosphatidylcholine
|
1.43 pmole
Standard Deviation 0.78
|
|
Tear Lipid Composition Profile
Oxygenated Phosphatidylcholine
|
0.04 pmole
Standard Deviation 0.03
|
|
Tear Lipid Composition Profile
Phosphatidylethanolamine
|
0.19 pmole
Standard Deviation 0.12
|
|
Tear Lipid Composition Profile
Phosphatidylserine
|
0.21 pmole
Standard Deviation 0.16
|
|
Tear Lipid Composition Profile
Sphingomyelin
|
0.75 pmole
Standard Deviation 0.34
|
|
Tear Lipid Composition Profile
Triacylglycerol
|
2.17 pmole
Standard Deviation 1.01
|
|
Tear Lipid Composition Profile
Wax Ester
|
45.14 pmole
Standard Deviation 5.24
|
|
Tear Lipid Composition Profile
(O-acyl)-omega-hydroxy fatty acid
|
1.18 pmole
Standard Deviation 0.60
|
Adverse Events
All Participants
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 A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is no more than 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER