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Safety and Tolerability of Artificial Tears in Dry Eye Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00932477
First received: July 1, 2009
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Safety and Tolerability of Artificial Tears in Dry Eye Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Tolerability Questionnaire Mean Scores at 1 Week [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
    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:
  • Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
    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.

  • Best-Corrected Visual Acuity (BCVA) Status at 1 Week [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
    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.

  • The Number of Ophthalmic Adverse Events at 1 Week [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
    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


Enrollment: 47
Study Start Date: August 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932477

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00932477     History of Changes
Other Study ID Numbers: AG9965-001
Study First Received: July 1, 2009
Results First Received: November 9, 2011
Last Updated: November 9, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
 Carboxymethylcellulose Sodium
Glycerol
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 13, 2013