Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
Phase 2
Completed
- Conditions
- Dry Eye Disease
- Interventions
- Drug: Hydroxypropyl Guar Galactomannan
- Registration Number
- NCT00760045
- Lead Sponsor
- Alcon Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Hydroxypropyl Guar Galactomannan AL-43546 0.15% 2 Hydroxypropyl Guar Galactomannan AL-43546 0.25% 3 Hydroxypropyl Guar Galactomannan AL-43546 0%(Vehicle) 4 0.1% sodium hyaluronate ophthalmic solution 0.1% sodium hyaluronate ophthalmic solutio
- Primary Outcome Measures
Name Time Method The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds). Up to 180 minutes
- Secondary Outcome Measures
Name Time Method Ocular comfort After installation
Trial Locations
- Locations (1)
Osaka Pharmacology Clinical Research Hospital
🇯🇵Osaka, Japan