Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects

Allergan288 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

288

Conditions

Dry Eye Syndrome

Interventions

Glycerin and Polysorbate 80 based artificial tearDRUG

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

Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tearDRUG

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

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline (Day 1), Day 90

Secondary Outcomes

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

Time frame: Baseline (Day 1), Day 90

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

Time frame: Baseline (Day 1), Day 90

Change From Baseline in Corneal Staining at 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).

Data from ClinicalTrials.gov

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