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Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

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ClinicalTrials.gov Identifier: NCT00514852
Recruitment Status : Completed
First Posted : August 10, 2007
Results First Posted : December 15, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
Allergan

Brief Summary:
The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: Carboxymethylcellulose and Glycerin based artificial tear Drug: Carboxymethylcellulose Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: 1
Carboxymethylcellulose and Glycerin based artificial tear
Drug: Carboxymethylcellulose and Glycerin based artificial tear
1 to 2 drops into each eye as needed but at least twice daily

Active Comparator: 2
Carboxymethylcellulose
Drug: Carboxymethylcellulose
1 to 2 drops into each eye as needed but at least twice daily
Other Name: Refresh Plus




Primary Outcome Measures :
  1. Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score [ Time Frame: Change from baseline at Day 30 ]

Secondary Outcome Measures :
  1. Change From Baseline at Day 30 in Schirmer Test, With Anesthesia [ Time Frame: Change from baseline at Day 30 ]
  2. Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein [ Time Frame: Change from baseline at Day 30 ]
  3. Patient Acceptability Score (Dryness) at Day 30 [ Time Frame: Day 30 ]
  4. Patient Acceptability Score (Vision) at Day 30 [ Time Frame: Day 30 ]
  5. Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein [ Time Frame: Change from baseline at Day 30 ]
  6. Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein [ Time Frame: Change from baseline at Day 30 ]
  7. Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score [ Time Frame: Change from baseline at Day 30 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • Use of systemic medications affecting dry eye
  • Pregnancy or planning a pregnancy
  • Contact lens wear

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): NCT00514852


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

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00514852     History of Changes
Other Study ID Numbers: AG9818-002
First Posted: August 10, 2007    Key Record Dates
Results First Posted: December 15, 2009
Last Update Posted: December 15, 2009
Last Verified: November 2009

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