Dry Eye Disease
Conditions
Brief summary
The purpose of the study is to observe lacrimal fluid condition (tear film break-up time) chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention time between them.
Interventions
DRUGHydroxypropyl Guar Galactomannan
One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.
One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects with NIBUT of either eye is 8 seconds or less and other eye is 10 seconds or less at screening test and NIBUT of either eye before instillation in Period I is 10 seconds or less.
Exclusion criteria
* Diagnosis of severe Sjogren's syndrome (history of the use of punctal plug one time or more, etc.) in either eye. * Subjects who will use ophthalmic solutions (excluding the specified artificial tear) or ophthalmic ointment in either eye during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds). | Up to 180 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Ocular comfort | After installation |
Countries
Japan
Outcome results
None listed