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

Dry Eye Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760045
• Other study ID #: C-07-54
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2008
• Last updated: January 5, 2010
• Start date: August 2008

Study information

• Verified date: January 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Eye Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Osaka Pharmacology Clinical Research Hospital	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline of non-invasive tear film break up time (?NIBUT: seconds).		Up to 180 minutes	No
Secondary	Ocular comfort		After installation	No