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

January 5, 2010 updated by: Alcon Research
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 532-0003
        • Osaka Pharmacology Clinical Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AL-43546 0.15%
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.
Experimental: 2
AL-43546 0.25%
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.
Active Comparator: 3
AL-43546 0%(Vehicle)
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.
Active Comparator: 4
0.1% sodium hyaluronate ophthalmic solutio
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds).
Time Frame: Up to 180 minutes
Up to 180 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Ocular comfort
Time Frame: After installation
After installation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 5, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-07-54

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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