Dry Eye
Conditions
Keywords
Dry Eye, Artificial Tears
Brief summary
To evaluate drop comfort, acceptability, preference and blue profile between two marketed artificial tears in both dry eyes and non-dry eye patient population.
Interventions
Systane Ultra Lubricant Eye Drops 1 drop each eye one time
Systane Lubricant Eye Drops 1 drop each eye one time
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of dry eye
Exclusion criteria
* Use of contact lens within 7 days preceding enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drop Comfort | once upon instillation | Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable, |
Countries
United States
Participant flow
Recruitment details
20 dry eye subjects
Pre-assignment details
Randomized, double-masked, cross-over design
Participants by arm
| Arm | Count |
|---|---|
| Overall Study | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Drop Comfort
Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,
Time frame: once upon instillation
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Systane Ultra | Drop Comfort | 0.55 Units on a scale | Standard Deviation 0.69 |
| Systane | Drop Comfort | 0.60 Units on a scale | Standard Deviation 0.68 |