A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of 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%
* Drug: sodium hyaluronate 0.18%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Use of artificial tears for dry eye in both eyes for at least 3 months Use of preservative-free artificial tears at least twice daily for 2 weeks; Exclusion Criteria: Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months Use of punctal plugs or contact lenses in the last month Active ocular allergy within last 2 years Best corrected visual acuity (BCVA) less than 20/200 in either eye

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 |
| --- | --- |
| Active Comparator: OPTIVE FUSION™<br>1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. | Drug: carboxymethylcellulose 0.5%/glycerin 0.9%<br>* 1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.<br>* Other names: OPTIVE FUSION™;|
| Active Comparator: VISMED® Multi<br>1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. | Drug: sodium hyaluronate 0.18%<br>* 1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.<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 in the Study Eye | Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal. | Baseline, Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Global Ocular Staining Score in the Study Eye | Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal. | Baseline, Month 3 | 
| Change From Baseline in Ocular Surface Disease Index© (OSDI) Score | The OSDI is a 12-question survey for patients to document their dry eye disease symptoms on a 5-point scale (0=none of the time and 4=all of the time). Higher scores represent greater disability. 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 and a positive number change from baseline represents a worsening. | Baseline, Day 35 | 
| Change From Baseline in the Schirmer Test in the Study Eye | The Schirmer's Test measures the rate of secretion of tears produced by the study eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening). | Baseline, Day 35 | 
| Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe). | Baseline, Day 35, Month 3 | 
| Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved). | Baseline, Day 35, Month 3 | 
| Subject Assessment of Treatment Acceptability on a 5-Point Scale | Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). | Day 35 | 
| Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor). | Day 35, Month 3 | 
| Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye | TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. 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) and a negative number change from baseline indicates a decrease in TBUT (worsening). | Baseline, Day 35 | 
| Work Productivity and Activity Impairment Questionnaire Score | The Work Productivity and Activity questionnaire assesses the effect of dry eye on the ability of subjects to work and perform regular activities on a scale from 0 to 10 during the past 7 days (0=dry eye had no effect on my work/daily activities to 10=dry eye completely prevented me from working/doing my daily activities). Since not all subjects were in full time employment during the study, not all items of the questionnaire were applicable to all subjects at each visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Baseline, Day 35, Month 3 | 
| Change From Baseline in Corneal Staining in the Study Eye | The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening). | Baseline, Day 35, Month 3 | 
| Change From Baseline in Conjunctival Staining in the Study Eye | The conjunctiva is the clear membrane covering the white surface of the eye. Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining) in the temporal and nasal locations. A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening). | Baseline, Day 35, Month 3 | 
| Conjunctival Hyperaemia in the Study Eye | Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe). | Baseline, Day 35, Month 3 | 
| Study Product Use | The number of times the study product is administered per day is recorded. | Day 8, Day 35, Month 3 |