Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00758784
First received: September 19, 2008
Last updated: January 3, 2013
Last verified: January 2013
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00758784     History of Changes
Other Study ID Numbers: CL-S&E-0417082-P
Study First Received: September 19, 2008
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014