Dry Eye
Conditions
Keywords
Dry eye, Artificial tear
Brief summary
To evaluate the acute comfort and blurring profile between two artificial tears in dry eye patients.
Interventions
OTHERLubricant Eye Drops FID 112903
Lubricant Eye Drops FID 112903 1 drop each eye 1 time
Optive Lubricant Eye Drops
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 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of dry eye * Must not have worn contact lenses for 1 week preceding enrollment
Exclusion criteria
* Age related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drop Comfort Upon Instillation | Three minutes | Drop comfort grading scale is a scale from 0 to 9, 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, crossover
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 | 18 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Drop Comfort Upon Instillation
Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.
Time frame: Three minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubricant Eye Drops FID 112903 | Drop Comfort Upon Instillation | 1.1 Units on a scale | Standard Deviation 1 |
| Lubricant Eye Drops | Drop Comfort Upon Instillation | 1.4 Units on a scale | Standard Deviation 1.6 |