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

Alcon Research40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Dry Eye Disease

Interventions

Hydroxypropyl Guar GalactomannanDRUG

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 solutionDRUG

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

Sex: ALLMin age: 20 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Osaka Pharmacology Clinical Research Hospital

Osaka, Osaka, Japan

Outcomes

Primary Outcomes

The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds).

Time frame: Up to 180 minutes

Secondary Outcomes

Ocular comfort

Time frame: After installation

Data from ClinicalTrials.gov

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