Evaluation of Ocular Comfort With ISTA Tears vs Systane

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01650584
First received: July 24, 2012
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

To evaluate the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED). There will also be an assessment of changes in ocular surface disease index (OSDI) score along with changes in worse symptom.


Condition Intervention
Dry Eye Disease
Drug: ISTA Tears
Drug: Systane

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 comfort [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISTA Tears
Sterile ophthalmic solution
Drug: ISTA Tears
sterile ophthalmic solution
Active Comparator: Systane
Sterile ophthalmic solution
Drug: Systane
Sterile ophthalmic solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OSDI >12

Exclusion Criteria:

  • Presence of any active ocular disease other than dry eye
  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: NCT01650584

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: NCT01650584     History of Changes
Other Study ID Numbers: S00231
Study First Received: July 24, 2012
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014