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

NCT ID: NCT00760045

Last Updated: 2010-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31

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.

Conditions

Dry Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

1

AL-43546 0.15%

Group Type: EXPERIMENTAL

Hydroxypropyl Guar Galactomannan

Intervention Type: DRUG

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.

2

AL-43546 0.25%

Group Type: EXPERIMENTAL

Hydroxypropyl Guar Galactomannan

Intervention Type: DRUG

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.

3

AL-43546 0%(Vehicle)

Group Type: ACTIVE_COMPARATOR

Hydroxypropyl Guar Galactomannan

Intervention Type: DRUG

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.

4

0.1% sodium hyaluronate ophthalmic solutio

Group Type: ACTIVE_COMPARATOR

0.1% sodium hyaluronate ophthalmic solution

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Alcon

Locations

Osaka Pharmacology Clinical Research Hospital

Osaka, Osaka, Japan

Countries

Japan

Other Identifiers

C-07-54

Identifier Type: -

Identifier Source: org_study_id