Artificial Tears Study in Mild to Moderate Dry Eye Patients

This study has been completed.
Sponsor:
Information provided by:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT00607776
First received: December 19, 2007
Last updated: February 5, 2008
Last verified: January 2008
  Purpose

The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.


Condition Intervention Phase
Dry Eye
Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400
Drug: Systane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Artificial Tears Study in Mild to Moderate Dry Eye Patients

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Subjective ocular comfort [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vision quality [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: January 2007
Study Completion Date: April 2007
Arms Assigned Interventions
Active Comparator: 1
Systane
Drug: Systane
Drops
Experimental: 2
Blink tears
Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400
Drops

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mild to moderate dry eye
  • over 18

Exclusion Criteria:

  • No concurrent ocular disease or meds
  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: NCT00607776

Sponsors and Collaborators
Abbott Medical Optics
Investigators
Principal Investigator: Eric Donnenfeld, M.D. Ophthalmic Consultants of Long Island
  More Information

No publications provided

Responsible Party: Lynn Lasswell, O.D., Director, Eye Care Clinical Research, AMO, Inc.
ClinicalTrials.gov Identifier: NCT00607776     History of Changes
Other Study ID Numbers: PEGT-104-9582
Study First Received: December 19, 2007
Last Updated: February 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Medical Optics:
dry, eyes
Amelioration of dry eye symptoms

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

ClinicalTrials.gov processed this record on September 30, 2014