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Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758784
First Posted: September 25, 2008
Last Update Posted: January 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  Purpose
The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.

Condition Intervention Phase
Dry Eye Disease Drug: Refresh Tears Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Ocular staining [ Time Frame: 2 months ]

Enrollment: 38
Study Start Date: August 2008
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Refresh Tears
sterile ophthalmic solution

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects 18 years of age or older

Exclusion Criteria:

  • No active ocular conditions of disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758784


Locations
United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00758784     History of Changes
Other Study ID Numbers: CL-S&E-0417082-P
First Submitted: September 19, 2008
First Posted: September 25, 2008
Last Update Posted: January 8, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions