Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Alcon Research
Treatments:
Hyaluronic Acid
Ophthalmic Solutions
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.