Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

Study Overview
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Brief Summary
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The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: Carboxymethylcellulose and Glycerin based artificial tear
* Drug: Carboxymethylcellulose


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 Use of systemic medications affecting dry eye Pregnancy or planning a pregnancy Contact lens wear

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Carboxymethylcellulose and Glycerin based artificial tear | Drug: Carboxymethylcellulose and Glycerin based artificial tear<br>* 1 to 2 drops into each eye as needed but at least twice daily<br>|
| Active Comparator: 2<br>Carboxymethylcellulose | Drug: Carboxymethylcellulose<br>* 1 to 2 drops into each eye as needed but at least twice daily<br>* Other names: Refresh Plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity) | Change from baseline at Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Schirmer Test measures the rate of the secretion of tears | Change from baseline at Day 30 | 
| Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein | Measures the stability of tear film. The average of 3 measures. | Change from baseline at Day 30 | 
| Patient Acceptability Score (Dryness) at Day 30 | Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all). | Day 30 | 
| Patient Acceptability Score (Vision) at Day 30 | Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better). | Day 30 | 
| Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein | Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining) | Change from baseline at Day 30 | 
| Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein | Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining) | Change from baseline at Day 30 | 
| Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score | Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe) | Change from baseline at Day 30 |