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Artificial Tears Study in Mild to Moderate Dry Eye Patients

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ClinicalTrials.gov Identifier: NCT00607776
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : February 6, 2008
Sponsor:
Information provided by:
Abbott Medical Optics

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 110 participants
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
Study Start Date : January 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Systane
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Subjective ocular comfort [ Time Frame: 1 Month ]

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


Information from the National Library of Medicine

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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

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

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 Posted: February 6, 2008    Key Record Dates
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