Back to resultsClinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Hydroxypropyl Guar Galactomannan
0.1% sodium hyaluronate ophthalmic solution
Sponsored by
About this trial
This is an interventional basic science trial for Dry Eye Disease
Eligibility Criteria
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.
Sites / Locations
- Osaka Pharmacology Clinical Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
AL-43546 0.15%
AL-43546 0.25%
AL-43546 0%(Vehicle)
0.1% sodium hyaluronate ophthalmic solutio
Outcomes
Primary Outcome Measures
The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds).
Secondary Outcome Measures
Ocular comfort
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00760045
Brief Title
Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AL-43546 0.15%
Arm Title
2
Arm Type
Experimental
Arm Description
AL-43546 0.25%
Arm Title
3
Arm Type
Active Comparator
Arm Description
AL-43546 0%(Vehicle)
Arm Title
4
Arm Type
Active Comparator
Arm Description
0.1% sodium hyaluronate ophthalmic solutio
Intervention Type
Drug
Intervention Name(s)
Hydroxypropyl Guar Galactomannan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.1% sodium hyaluronate ophthalmic solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds).
Time Frame
Up to 180 minutes
Secondary Outcome Measure Information:
Title
Ocular comfort
Time Frame
After installation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Osaka Pharmacology Clinical Research Hospital
City
Osaka
ZIP/Postal Code
532-0003
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
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