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Safety and Tolerability of Artificial Tears in Dry Eye Subjects

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.
ClinicalTrials.gov Identifier: NCT00932477
Recruitment Status : Completed
First Posted : July 3, 2009
Results First Posted : December 13, 2011
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.

Condition or disease Intervention/treatment
Dry Eye Syndrome Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear Drug: Glycerin and Polysorbate 80 based artificial tear

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Safety and Tolerability of Artificial Tears in Dry Eye Subjects
Study Start Date : August 2009
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Tears
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Artificial Tear Formulation 1
Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
1 to 2 drops into each eye three times per day
Experimental: Artificial Tear Formulation 2
Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
1 to 2 drops into each eye three times per day
Active Comparator: Glycerin and Polysorbate 80 based artificial tear
Glycerin and Polysorbate 80 based artificial tear
Drug: Glycerin and Polysorbate 80 based artificial tear
1 to 2 drops into each eye three times per day
Other Name: Refresh Dry Eye Therapy®


Outcome Measures

Primary Outcome Measures :
  1. Tolerability Questionnaire Mean Scores at 1 Week [ Time Frame: 1 Week ]
    Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.


Secondary Outcome Measures :
  1. Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week [ Time Frame: 1 Week ]
    Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening.

  2. Best-Corrected Visual Acuity (BCVA) Status at 1 Week [ Time Frame: 1 Week ]
    BCVA status at 1 week reported as the number of patients whose scores were either "Better", "No Change", or "Worse" than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. "Better" equals increase of 2 lines or more in at least 1 eye; "No Change" equals change between -2 to +2 lines in either eye; "Worse" equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly.

  3. The Number of Ophthalmic Adverse Events at 1 Week [ Time Frame: 1 Week ]
    The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product


Eligibility Criteria

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:   No
Criteria

Inclusion Criteria:

  • Mild, moderate or severe symptoms of dry eye

Exclusion Criteria:

  • Uncontrolled systemic disease
  • Contact lens wear
  • Participation in another clinical study
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): NCT00932477


Locations
United States, California
San Diego, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00932477     History of Changes
Other Study ID Numbers: AG9965-001
First Posted: July 3, 2009    Key Record Dates
Results First Posted: December 13, 2011
Last Update Posted: August 26, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Glycerol
Lubricant Eye Drops
Carboxymethylcellulose Sodium
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Ophthalmic Solutions
Pharmaceutical Solutions
Laxatives
Gastrointestinal Agents