Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects

Study Overview
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Brief Summary
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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.

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glycerin and Polysorbate 80 based artificial tear<br>Glycerin and Polysorbate 80 based artificial tear | Drug: Glycerin and Polysorbate 80 based artificial tear<br>* 1-2 drops in each eye, as needed, but at least twice daily<br>* Other names: Refresh Dry Eye Therapy® Lubricant Eye Drops;|
| Experimental: Artificial Tears Formulation 1<br>Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear | Drug: Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear<br>* 1-2 drops in each eye, as needed, but at least twice daily<br>|
| Experimental: Artificial Tears Formulation 2<br>Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear | Drug: Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear<br>* 1-2 drops in each eye, as needed, but at least twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 1), Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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). | Baseline (Day 1), Day 90 | 
| Change From Baseline in Conjunctival Staining Severity Score at 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). | Baseline (Day 1), Day 90 |