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

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00760045

Purpose

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	Intervention	Phase
Dry Eye Disease	Drug: Hydroxypropyl Guar Galactomannan Drug: 0.1% sodium hyaluronate ophthalmic solution	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases

Drug Information available for: Hyaluronic acid Hyaluronate Sodium

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds). [ Time Frame: Up to 180 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ocular comfort [ Time Frame: After installation ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	August 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760045

Locations

Japan
Osaka Pharmacology Clinical Research Hospital
Osaka, Japan, 532-0003

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Koji Hasegawa, Alcon
ClinicalTrials.gov Identifier:	NCT00760045 History of Changes
Other Study ID Numbers:	C-07-54
Study First Received:	September 24, 2008
Last Updated:	January 5, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012