Dry Eye
Conditions
Keywords
Dry Eye, Artificial Tears,
Brief summary
To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients
Interventions
Systane Ultra Lubricant Eye Drops one drop each eye one time
Optive Lubricant Eye Drops one drop each eye one time
OTHERBlink Tears
Blink Tears one drop each eye one time
OTHERGenTeal Moderate Lubricant Eye Drops
GenTeal Moderate Lubricant Eye Drops one 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 topical ocular drops within 2 hours 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 | 17 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 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 (MEAN) | Dispersion |
|---|---|---|---|
| Systane Ultra Lubricant Eye Drops | Drop Comfort | 0.7 units on a scale | Standard Deviation 1.26 |
| Optive Lubricant Eye Drops | Drop Comfort | 1.05 units on a scale | Standard Deviation 1.1 |
| Blink Tears | Drop Comfort | 1.84 units on a scale | Standard Deviation 2.19 |
| GenTeal Moderate Lubricant Eye Drops | Drop Comfort | 1.1 units on a scale | Standard Deviation 1.21 |