Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms

Study Overview
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Brief Summary
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To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease.

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: carboxymethylcellulose 0.5% +glycerin 0.9%
* Drug: sodium hyaluronate 0.18%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness). Be likely to complete the entire course of study and to comply with appropriate instructions Exclusion Criteria: Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months. Have uncontrolled systemic disease Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears Have anticipated contact lens wear during the study Have an active ocular infection

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 |
| --- | --- |
| Active Comparator: 1<br>carboxymethylcellulose 0.5%, glycerin 0.9% | Drug: carboxymethylcellulose 0.5% +glycerin 0.9%<br>* To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.<br>* Other names: Optive™ Sensitive;|
| Active Comparator: 2<br>sodium hyaluronate 0.18% | Drug: sodium hyaluronate 0.18%<br>* To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.<br>* Other names: Vismed®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 | Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement. | Baseline, Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Tear Breakup Time (TBUT) at Week 2 | Change from baseline in TBUT at Week 2. TBUT is defined as 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 positive number change from baseline indicates improvement. | Baseline, Week 2 | 
| Change From Baseline in Corneal Staining at Week 2 | Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. | Baseline, Week 2 | 
| Change From Baseline in Conjunctival Staining (Temporal) at Week 2 | Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. | Baseline, Week 2 | 
| Change From Baseline in Conjunctival Staining (Nasal) at Week 2 | Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. | Baseline, Week 2 |