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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00760045
First received: September 24, 2008
Last updated: January 5, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Dry Eye Disease
Drug: Hydroxypropyl Guar Galactomannan
Drug: 0.1% sodium hyaluronate ophthalmic solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds). [ Time Frame: Up to 180 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ocular comfort [ Time Frame: After installation ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760045

Locations
Japan
Osaka Pharmacology Clinical Research Hospital
Osaka, Japan, 532-0003
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Koji Hasegawa, Alcon
ClinicalTrials.gov Identifier: NCT00760045     History of Changes
Other Study ID Numbers: C-07-54
Study First Received: September 24, 2008
Last Updated: January 5, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014