Comparative Study of Rohto Dry-Aid® and Systane® Ultra in Patients With Dry Eye

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye.

Official Title
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A Randomized, Single-Center, Comparative Study of Rohto Dry-Aid® and Systane® Ultra in the Management of Tear Film Stability and Visual Function in Patients With Dry Eye

Conditions
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Dry Eye Syndromes, Dry Eye

Intervention / Treatment
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* Drug: Rohto Dry-Aid®
* Drug: Systane® Ultra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age Provide written informed consent Have a reported history of dry eye Have a history of use of eye drops for dry eye symptoms Ocular discomfort Conjunctival redness Tear film break up time Corneal and Conjunctival Staining Exclusion Criteria: Have any clinically significant slit lamp findings at entry visit Be diagnosed with an ongoing ocular infection Have any planned ocular and/or lid surgeries over the study period Have an uncontrolled systemic disease Be a woman who is pregnant, nursing or planning a pregnancy Be a woman of childbearing potential who is not using an acceptable means of birth control Have a known allergy and/or sensitivity to the test article or its components Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

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: Active<br> | Drug: Rohto Dry-Aid®<br> <br> |
| Active Comparator: Active Comparator<br> | Drug: Systane® Ultra<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry Eye Staining | Dry eye syndrome corneal and conjunctival staining assessment | 28 days | 
| Dry Eye Symptom Questionnaire | Symptom assessment questionnaire | 28 days | 
| Tear Film Break Up Time | Tear Film Break Up Time after instillation of fluorescein dye | 28 days | 
| Visual Function Assessment | Reading Test | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop Comfort Assessment | The comfort of the eye drop will be performed to assess changes from baseline | Day 1 | 
| Visual Acuity | Visual Acuity will be measured using the EDTRS chart to assess changes from baseline | 28 Days | 
| Slit-Lamp Biomicroscopy | Slit lamp biomicroscopy exams will be performed to assess any changes from baseline | 28 Days | 
| Adverse Event | Adverse Event queries | 28 Days |