A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.

Official Title
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A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Carboxymethylcellulose Based Eye Drop
* Drug: Carboxymethylcellulose Sodium 0.5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Used artificial tears for dry eye Visual acuity of at least 20/32 (while wearing glasses, if necessary). Exclusion Criteria: Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study Herpes keratitis in the last 6 months Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months

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: OM3 Tear<br>Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. | Drug: Carboxymethylcellulose Based Eye Drop<br>* Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.<br>|
| Active Comparator: REFRESH OPTIVE® ADVANCED<br>Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. | Drug: Carboxymethylcellulose Sodium 0.5%<br>* Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.<br>* Other names: REFRESH OPTIVE® ADVANCED;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was 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 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement. | Baseline, Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Tear Break-up Time (TBUT) | 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. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening. | Baseline, Day 90 | 
| Change From Baseline in Corneal Staining Score | Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | Baseline, Day 90 | 
| Change From Baseline in Conjunctival Staining Score | Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | Baseline, Day 90 | 
| Change From Baseline in the Schirmer Test | The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement). | Baseline, Day 90 |