Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00760045
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: Hydroxypropyl Guar Galactomannan; Drug: 0.1% sodium hyaluronate ophthalmic solution	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 AL-43546 0.15%	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.
Experimental: 2 AL-43546 0.25%	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.
Active Comparator: 3 AL-43546 0%(Vehicle)	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.
Active Comparator: 4 0.1% sodium hyaluronate ophthalmic solutio	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.

Outcome Measures

Primary Outcome Measures

1. The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds). [Up to 180 minutes]

Secondary Outcome Measures

1. Ocular comfort [After installation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osaka Pharmacology Clinical Research Hospital	Osaka		Japan	532-0003

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00760045
• Other Study ID Numbers: C-07-54
• First Posted: Sep 25, 2008
• Last Update Posted: Jan 6, 2010
• Last Verified: Jan 1, 2010

• Additional relevant MeSH terms: Dry Eye Syndromes; Eye Diseases; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Hyaluronic Acid

Study Results

No Results Posted as of Jan 6, 2010