Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease

Study Overview
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Brief Summary
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This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Carboxymethylcellulose Based Eye Drop Formulation A
* Drug: Carboxymethylcellulose Based Eye Drop Formulation B
* Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops
* Drug: Carboxymethylcellulose Based Lubricant Eye Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dry eyes Current use of eye drops for dry eye at least twice daily, on average for at least 3 months Exclusion Criteria: Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months Active ocular allergy

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboxymethylcellulose Based Eye Drop Formulation A<br>Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. | Drug: Carboxymethylcellulose Based Eye Drop Formulation A<br>* Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.<br>* Other names: Refresh Optive® Advanced Sensitive Eye Drops;|
| Experimental: Carboxymethylcellulose Based Eye Drop Formulation B<br>Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. | Drug: Carboxymethylcellulose Based Eye Drop Formulation B<br>* Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.<br>* Other names: Refresh Optive® Advanced Eye Drops;|
| Active Comparator: Carboxymethylcellulose Preservative-Free Lubricant Eye Drops<br>Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. | Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops<br>* Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.<br>* Other names: Optive® Sensitive Preservative-Free Lubricant Eye Drops;|
| Active Comparator: Carboxymethylcellulose Based Lubricant Eye Drops<br>Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. | Drug: Carboxymethylcellulose Based Lubricant Eye Drops<br>* Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.<br>* Other names: Optive® Lubricant Eye Drops;|

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© Questionnaire Score | The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement. | Baseline, Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Tear Break-up Time | Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement. | Baseline, Day 30 | 
| Change From Baseline in Corneal Staining | The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement). | Baseline, Day 30 | 
| Change From Baseline in Conjunctival Staining | The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement). | Baseline, Day 30 | 
| Change From Baseline in Schirmer Test Results | The Schirmer Test measures the rate of the secretion of tears produced by the 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. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement). | Baseline, Day 30 |