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

Alcon

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: 0.1% sodium hyaluronate ophthalmic solution; Drug: Hydroxypropyl Guar Galactomannan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00760045

C-07-54

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 4 patient groups

1

Experimental group

Description:

AL-43546 0.15%

Treatment:

Drug: Hydroxypropyl Guar Galactomannan

2

Experimental group

Description:

AL-43546 0.25%

Treatment:

Drug: Hydroxypropyl Guar Galactomannan

3

Active Comparator group

Description:

AL-43546 0%(Vehicle)

Treatment:

Drug: Hydroxypropyl Guar Galactomannan

4

Active Comparator group

Description:

0.1% sodium hyaluronate ophthalmic solutio

Treatment:

Drug: 0.1% sodium hyaluronate ophthalmic solution