A Safety and Efficacy Study of Refresh Optive® Gel Drops 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 o fRefresh Optive® Gel Drops in patients with dry eye disease.

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Refresh Optive® Gel Drops
* Drug: REFRESH LIQUIGEL®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current use of an artificial tear product 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 Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months Current eye infection or inflammation

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: Refresh Optive® Gel Drops<br>Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. | Drug: Refresh Optive® Gel Drops<br>* Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.<br>|
| Active Comparator: REFRESH LIQUIGEL®<br>REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days. | Drug: REFRESH LIQUIGEL®<br>* REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.<br>|

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 is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The 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. | Baseline, Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the OSDI© Score | The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The 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. | Baseline, Day 7 | 
| Change From Baseline in Tear Break-up Time (TBUT) | TBUT is 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 short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). The eye with shorter average TBUT at baseline is reported for each patient. | Baseline, Day 30 | 
| Change From Baseline in the Combined Corneal and Conjunctival Staining Scores | The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject. | Baseline, Day 30 | 
| Change From Baseline in the Schirmer Test | The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject. | Baseline, Day 30 |