Dry Eye Disease
Conditions
Brief summary
To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)
Interventions
DRUGISTA Tears
sterile ophthalmic solution
DRUGSystane
Sterile ophthalmic solution
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* OSDI \>12
Exclusion criteria
* Presence of any active ocular disease other than dry eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Preference for One of the Treatments | 30 days | There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). Participants were asked to indicate which treatment they preferred, or if they preferred neither. |
Countries
United States
Participant flow
Recruitment details
There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total).
Participants by arm
| Arm | Count |
|---|---|
| All Participants Received Both ISTA Tears and Systane ISTA Tears: sterile ophthalmic solution used in the right eye.
Systane: Sterile ophthalmic solution used in the left eye. | 35 |
| All Participants Received Both ISTA Tears and Systane ISTA Tears: sterile ophthalmic solution used in the right eye.
Systane: Sterile ophthalmic solution used in the left eye. | 70 |
| Total | 105 |
Baseline characteristics
| Characteristic | All Participants Received Both ISTA Tears and Systane |
|---|---|
| Age, Customized At least 18 years of age | 35 Participants |
| Region of Enrollment United States | 35 Participants |
| Sex/Gender, Customized Both male or female | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Percentage of Participants With Preference for One of the Treatments
There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). Participants were asked to indicate which treatment they preferred, or if they preferred neither.
Time frame: 30 days
Population: There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Participants | Percentage of Participants With Preference for One of the Treatments | ISTA Tears preferred | 23 Participants |
| Overall Participants | Percentage of Participants With Preference for One of the Treatments | Neither preferred | 1 Participants |
| Overall Participants | Percentage of Participants With Preference for One of the Treatments | Systane preferred | 11 Participants |