Safety and Tolerability of Artificial Tears in Dry Eye Subjects

Study Overview
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Brief Summary
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The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.

Official Title
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Safety and Tolerability of Artificial Tears in Dry Eye Subjects

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
* Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
* Drug: Glycerin and Polysorbate 80 based artificial tear


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild, moderate or severe symptoms of dry eye Exclusion Criteria: Uncontrolled systemic disease Contact lens wear Participation in another clinical 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial Tear 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 to 2 drops into each eye three times per day<br>|
| Experimental: Artificial Tear 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 to 2 drops into each eye three times per day<br>|
| 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 to 2 drops into each eye three times per day<br>* Other names: Refresh Dry Eye Therapy®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability Questionnaire Mean Scores at 1 Week | Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst. | 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week | Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening. | 1 Week | 
| Best-Corrected Visual Acuity (BCVA) Status at 1 Week | BCVA status at 1 week reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more in at least 1 eye; No Change equals change between -2 to +2 lines in either eye; Worse equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. | 1 Week | 
| The Number of Ophthalmic Adverse Events at 1 Week | The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product | 1 Week |