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
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

ClinicalTrials.gov processed this record on April 17, 2014