Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
NCT00760045 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2010-01-06
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.
Conditions
Interventions
- DRUG
-
Hydroxypropyl 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.
- DRUG
-
0.1% sodium hyaluronate ophthalmic solution
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 & Collaborators
-
Alcon Research
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-08-31
- Primary Completion
- 2008-10-31
Countries
- Japan
Study Locations
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