Healthy Volunteers
Conditions
Brief summary
This exploratory study will collect tear samples from adult volunteers for determining and quantifying tear composition profiles. No investigational drug will be administered in this study.
Interventions
PROCEDURETear Sample Collection
Tear sample collection as per protocol. No investigational drug is administered in this study.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
-Adult volunteers without ocular disease.
Exclusion criteria
* Systemic medications that could affect eye health taken within 1 month of enrollment * Eye infection or inflammation in either eye 3 months prior to screening * History of herpes in either eye * Diagnosis of dry eye or meibomian gland dysfunction * Diagnosis of glaucoma * Allergic conjunctivitis * Use of rigid contact lenses within 1 year of screening * Use of soft contact lenses within 1 week of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Lipid Composition Profile | Day 1 | 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). |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 23.0 years STANDARD_DEVIATION 4.2 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Tear Lipid Composition Profile
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).
Time frame: Day 1
Population: A subset of enrolled participants who had non-stimulated (basal) tear samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Tear Lipid Composition Profile | Cholesterol Ester | 39.34 pmole | Standard Deviation 6.78 |
| All Participants | Tear Lipid Composition Profile | Lyso- Phosphatidylcholine | 1.48 pmole | Standard Deviation 0.71 |
| All Participants | Tear Lipid Composition Profile | Lyso- Phosphatidylethanolamine | 0.74 pmole | Standard Deviation 0.74 |
| All Participants | Tear Lipid Composition Profile | Phosphatidylserine | 0.21 pmole | Standard Deviation 0.16 |
| All Participants | Tear Lipid Composition Profile | Sphingomyelin | 0.75 pmole | Standard Deviation 0.34 |
| All Participants | Tear Lipid Composition Profile | (O-acyl)-omega-hydroxy fatty acid | 1.18 pmole | Standard Deviation 0.6 |
| All Participants | Tear Lipid Composition Profile | Phosphatidylethanolamine | 0.19 pmole | Standard Deviation 0.12 |
| All Participants | Tear Lipid Composition Profile | Diacylglycerol | 0.76 pmole | Standard Deviation 0.49 |
| All Participants | Tear Lipid Composition Profile | Free Cholesterol | 6.58 pmole | Standard Deviation 3.11 |
| All Participants | Tear Lipid Composition Profile | Phosphatidylcholine | 1.43 pmole | Standard Deviation 0.78 |
| All Participants | Tear Lipid Composition Profile | Oxygenated Phosphatidylcholine | 0.04 pmole | Standard Deviation 0.03 |
| All Participants | Tear Lipid Composition Profile | Triacylglycerol | 2.17 pmole | Standard Deviation 1.01 |
| All Participants | Tear Lipid Composition Profile | Wax Ester | 45.14 pmole | Standard Deviation 5.24 |