Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.

Official Title
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Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye

Conditions
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Dry Eye Syndromes, Keratoconjunctivitis Sicca

Intervention / Treatment
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* Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
* Drug: sodium hyaluronate 0.18% (VISMED® Multi)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been using artificial tears for at least 3 months prior to study inclusion Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion Having moderate to severe symptoms suggestive of dry eye Exclusion Criteria: Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study Moderate to severe blepharitis History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months History or active signs of ocular allergic disease or ocular herpes within the last year History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD) | Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)<br>* One drop in each eye three to six times daily, as needed<br>* Other names: OPTIVE® MD;|
| Active Comparator: 2<br>sodium hyaluronate 0.18% (VISMED® Multi) | Drug: sodium hyaluronate 0.18% (VISMED® Multi)<br>* One drop in each eye three to six times daily, as needed<br>* Other names: VISMED® Multi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Global Ocular Staining Score at Day 35 | Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst). | Baseline, Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 | Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms. | Baseline, Day 35 |