Dry Eye
Conditions
Keywords
Dry eye
Brief summary
To evaluate drop comfort, acceptability, preference and blur profile between two marketed artificial tears in both dry eye and non-dry eye patient population.
Interventions
Systane Lubricant Eye Drops 1 drop each eye once time
Optive Lubricant Eye Drops 1 drop each eye one time
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy, normal eyes OR documented diagnosis of dry eye
Exclusion criteria
* Must not have worn contact lenses for 7 days preceding enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Blur | 3 minutes post dose | Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes. |
Participant flow
Recruitment details
Medical Clinic Nov. 2007
Pre-assignment details
24 hr. wash out between treatment periods
Participants by arm
| Arm | Count |
|---|---|
| Systane Drops Then Optive Drops Systane Drops then Optive Drops | 20 |
| Optive Drops Then Systane Drops Optive Drops then Systane Drops | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Systane Drops Then Optive Drops | Optive Drops Then Systane Drops | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Visual Blur
Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.
Time frame: 3 minutes post dose
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Systane Lubricant Eye Drops | Visual Blur | 27.7 Units on a scale |
| Optive Lubricant Eye Drops | Visual Blur | 33.55 Units on a scale |