Dry Eye
Conditions
Brief summary
To evaluate the effect of 2 different lubricant eye drops on visual function of patients with dry eye
Interventions
Systane Ultra Lubricant Eye Drops 1 drop each eye one 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
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of dry eye * Must not have worn contact lenses for 12 hours prior to Day 1
Exclusion criteria
* Age related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time at Best Corrected Visual Acuity | 15 minutes, 45 minutes, and 90 minutes post-dose | Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Blink Rate Time (Time Between Blinks) | 15 minutes, 45 minutes, and 90 minutes post-dose | Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance. |
Countries
United States
Participant flow
Recruitment details
48 Dry Eye Subjects
Pre-assignment details
Randomized, double-masked, crossover
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Overall Study | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 22 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
Time at Best Corrected Visual Acuity
Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.
Time frame: 15 minutes, 45 minutes, and 90 minutes post-dose
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Systane Ultra | Time at Best Corrected Visual Acuity | 15 minutes post-dose | 7.75 seconds | Standard Error 0.6545 |
| Systane Ultra | Time at Best Corrected Visual Acuity | 45 minutes post-dose | 6.46 seconds | Standard Error 0.4003 |
| Systane Ultra | Time at Best Corrected Visual Acuity | 90 minutes post-dose | 9.17 seconds | Standard Error 0.0365 |
| Optive | Time at Best Corrected Visual Acuity | 15 minutes post-dose | 6.42 seconds | Standard Error 0.6545 |
| Optive | Time at Best Corrected Visual Acuity | 45 minutes post-dose | 5.51 seconds | Standard Error 0.4003 |
| Optive | Time at Best Corrected Visual Acuity | 90 minutes post-dose | 6.84 seconds | Standard Error 0.0365 |
Secondary
Functional Blink Rate Time (Time Between Blinks)
Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance.
Time frame: 15 minutes, 45 minutes, and 90 minutes post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Ultra | Functional Blink Rate Time (Time Between Blinks) | 15 minutes post-dose | 5.9 seconds | Standard Deviation 5.5 |
| Systane Ultra | Functional Blink Rate Time (Time Between Blinks) | 45 minutes post-dose | 5.9 seconds | Standard Deviation 5.4 |
| Systane Ultra | Functional Blink Rate Time (Time Between Blinks) | 90 minutes post-dose | 6.5 seconds | Standard Deviation 5.8 |
| Optive | Functional Blink Rate Time (Time Between Blinks) | 15 minutes post-dose | 5.8 seconds | Standard Deviation 4.7 |
| Optive | Functional Blink Rate Time (Time Between Blinks) | 45 minutes post-dose | 6.7 seconds | Standard Deviation 4.9 |
| Optive | Functional Blink Rate Time (Time Between Blinks) | 90 minutes post-dose | 7.3 seconds | Standard Deviation 6 |