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Completed

NCT Number: NCT01010282

Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects

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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glycerin and Polysorbate 80 based artificial tear

Drug

1-2 drops in each eye, as needed, but at least twice daily

Other names: Refresh Dry Eye Therapy® Lubricant Eye Drops

Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

Drug

1-2 drops in each eye, as needed, but at least twice daily

Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear

Drug

1-2 drops in each eye, as needed, but at least twice daily

Primary outcomes

  1. Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90

    Time frame: Baseline (Day 1), Day 90

    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 outcomes

  1. Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90

    Time frame: Baseline (Day 1), Day 90

    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.

  2. Change From Baseline in Tear Break-up Time (TBUT) at Day 90

    Time frame: Baseline (Day 1), Day 90

    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).

  3. Change From Baseline in Corneal Staining at Day 90

    Time frame: Baseline (Day 1), Day 90

    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).

  4. Change From Baseline in Conjunctival Staining Severity Score at Day 90

    Time frame: Baseline (Day 1), Day 90

    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).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 10, 2009
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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