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Artificial Tears Study in Mild to Moderate Dry Eye Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00607776
First Posted: February 6, 2008
Last Update Posted: February 6, 2008
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:
Abbott Medical Optics
  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 (Participant, 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 ]

Secondary Outcome Measures:
  • Vision quality [ Time Frame: 1 Month ]

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

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:   Yes
Criteria

Inclusion Criteria:

  • Mild to moderate dry eye
  • over 18

Exclusion Criteria:

  • No concurrent ocular disease or meds
  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): NCT00607776


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

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
First Submitted: December 19, 2007
First Posted: February 6, 2008
Last Update Posted: February 6, 2008
Last Verified: January 2008

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
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions