Dry Eye
Conditions
Brief summary
Single site, prospective, double-masked, randomized-controlled, two-arm study of the dry eye symptoms as well as corneal and conjunctival staining in subjects using 2 different eyedrops. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include patient questionnaire, tear-breakup time, and slit lamp exam.
Interventions
DRUGSystane Complete Multi-Dose PF
Eyedrop
DRUGWalgreen's Lubricant Balance
Eyedrop
Sponsors
Sengi
Scripps Poway Eyecare and Optometry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. * Subjects who currently have mild to moderate symptoms of dry eye as defined by a screening SANDE score of 20-55 inclusive (equivalent to OSDI score of 12 -32).2 * Subjects between the ages of 18-65. * Subjects willing to comply with the prescribed regimen and schedule of eye drops. * Subjects willing to attend all study visits. * Subjects willing to discontinue any current artificial tear use 24 hours prior to the baseline study visit.
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SANDE Questionnaire | Change from baseline to 2 weeks | The Symptom Assessment iN Dry Eye (SANDE) questionnaire. Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root\[Q1 \* Q2\]. Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Corneal and Conjunctival Staining | Change from baseline to 2 weeks | Baseline corneal and conjunctival staining with sodium fluorescein and Wratten filter assessed OU using the Academy of Ophthalmology 5 quadrant scheme. Each quadrant will be graded (0-3) giving a total score (by summation) of 0-15 per eye. A higher score is a worse outcome. |
| Non-invasive Tear Breakup Time | Change from baseline to 2 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Systane Complete Multi-Dose PF Systane Complete Multi-Dose PF: Eyedrop | 35 |
| Walgreen's Lubricant Balance Walgreen's Lubricant Balance: Eyedrop | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Systane Complete Multi-Dose PF | Walgreen's Lubricant Balance | Total |
|---|---|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 14.2 | 39.4 years STANDARD_DEVIATION 15.1 | 40.8 years STANDARD_DEVIATION 14.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 18 Participants | 43 Participants |
| Sex: Female, Male Male | 10 Participants | 17 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
SANDE Questionnaire
The Symptom Assessment iN Dry Eye (SANDE) questionnaire. Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root\[Q1 \* Q2\]. Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms.
Time frame: Change from baseline to 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Systane Complete Multi-Dose PF | SANDE Questionnaire | -7.2 score | Standard Deviation 11.7 |
| Walgreen's Lubricant Balance | SANDE Questionnaire | -2.2 score | Standard Deviation 6 |
Other Pre-specified
Corneal and Conjunctival Staining
Baseline corneal and conjunctival staining with sodium fluorescein and Wratten filter assessed OU using the Academy of Ophthalmology 5 quadrant scheme. Each quadrant will be graded (0-3) giving a total score (by summation) of 0-15 per eye. A higher score is a worse outcome.
Time frame: Change from baseline to 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Systane Complete Multi-Dose PF | Corneal and Conjunctival Staining | -2.8 score | Standard Deviation 1.8 |
| Walgreen's Lubricant Balance | Corneal and Conjunctival Staining | -0.9 score | Standard Deviation 1.5 |
Other Pre-specified
Non-invasive Tear Breakup Time
Time frame: Change from baseline to 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Systane Complete Multi-Dose PF | Non-invasive Tear Breakup Time | 3.1 seconds | Standard Deviation 2.9 |
| Walgreen's Lubricant Balance | Non-invasive Tear Breakup Time | 2.2 seconds | Standard Deviation 4.5 |