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Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01010282
First received: November 6, 2009
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.


Condition Intervention
Dry Eye Syndrome
 Drug: Glycerin and Polysorbate 80 based artificial tear
Drug: Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear
Drug: Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90 [ Time Frame: Baseline (Day 1), Day 90 ] [ Designated as safety issue: No ]
    Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.


Secondary Outcome Measures:
  • Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90 [ Time Frame: Baseline (Day 1), Day 90 ] [ Designated as safety issue: No ]
    Change from baseline in the OSDI total score at day 90. The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.

  • Change From Baseline in Tear Break-up Time (TBUT) at Day 90 [ Time Frame: Baseline (Day 1), Day 90 ] [ Designated as safety issue: No ]
    Change from baseline in TBUT at day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).

  • Change From Baseline in Corneal Staining at Day 90 [ Time Frame: Baseline (Day 1), Day 90 ] [ Designated as safety issue: No ]
    Change from baseline in corneal staining at day 90. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).

  • Change From Baseline in Conjunctival Staining Severity Score at Day 90 [ Time Frame: Baseline (Day 1), Day 90 ] [ Designated as safety issue: No ]
    Change from baseline in conjunctival staining severity score at day 90. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).


Enrollment: 288
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glycerin and Polysorbate 80 based artificial tear
Glycerin and Polysorbate 80 based artificial tear
 Drug: Glycerin and Polysorbate 80 based artificial tear
1-2 drops in each eye, as needed, but at least twice daily
Other Name: Refresh Dry Eye Therapy® Lubricant Eye Drops
Experimental: Artificial Tears 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
1-2 drops in each eye, as needed, but at least twice daily
Experimental: Artificial Tears 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
1-2 drops in each eye, as needed, but at least twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average
  • Ability/agreement to wear habitual correction (glasses) during study period

Exclusion Criteria:

  • Known allergy or sensitivity to the study product(s) or its components
  • Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months
  • Chronic use of systemic medications which may affect a dry eye condition
  • Active ocular allergy or infection
  • Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1
  • Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010282

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: NCT01010282     History of Changes
Other Study ID Numbers: AG9965-002
Study First Received: November 6, 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 May 23, 2013