Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients

Study Overview
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Brief Summary
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This is a double-masked, randomized, bilateral, 2-Arm parallel group study. Subjects are scheduled for 3 study visits (screening/baseline, 7-Day and 30-Day follow-up visits) over a period of one month.

Official Title
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Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: 9618X investigational lipid eye drops
* Device: Blink® Tears


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all the following criteria to be enrolled in the study: Subjects must be at least 18 years of age and no more than 69 years of age (inclusive). Subjects must be non-contact lens wearers. Subjects must achieve visual acuity of 20/30 or better in each eye, either unaided or best corrected. Subjects must possess a functional/usable pair of spectacles and bring them to every visit (only if applicable - to the investigators discretion). Self-reported symptoms of ocular dryness or irritation and/or the use of artificial tears in the last 3 months. Subjects must read, understand, and sign the Statement of Informed Consent. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Currently pregnant or breast-feeding. Diabetes. Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the investigator's discretion). Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the investigator's discretion). Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA scale. Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc.). Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK). Participation in any pharmaceutical or medical device related clinical trial within 30 days prior to study enrollment. History of binocular vision abnormality or strabismus. Habitual wearers of soft contact lenses in the past 1 month or rigid gas permeable lens within the past 3 months. Current habitual use of Prescription Medicines to treat dry eye or ocular discomfort, ocular steroids, or any medication (RX or OTC) that would interfere with the clinical study (at the discretion of the investigator). Employees of investigational clinic (investigator, coordinator, and technician, etc.) or family member of an employee of the clinical site by self-report. In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain (Castor Oil, Polyoxyl 40 Hydrogenated Castor Oil, Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate, Purified Water) should not participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Test Eye Drops<br>Eligible subjects that are non-contact lens wearers will be randomized to the Test group throughout the duration of the study. | Device: 9618X investigational lipid eye drops<br>* Test Eye Drops<br>|
| Active Comparator: Control Eye Drops<br>Eligible subjects that are non-contact lens wearers will be randomized to the Control group throughout the duration of the study. | Device: Blink® Tears<br>* Control Eye Drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Ocular Comfort (30-Day) | Subjective overall ocular comfort was assessed at baseline, and at the 30-Day follow-up using a Visual Analogue Scale (VAS) ranging from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 30-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was report. | Baseline and 30-Day Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Ocular Comfort (7-Day) | Subjective overall ocular comfort was assessed at baseline, and at the 7-Day follow-up using a Visual Analogue Scale (VAS) ranging from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 7-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was report. | Baseline and 7-Day Follow-up | 
| Number of Subject Eyes That Reported Ocular Symptoms | Subjects were reported whether they experienced any ocular symptoms, problems or complaints (yes/no) by eye. Ocular symptoms were assessed for each subject eye at all study visits (scheduled and unscheduled). The number of eyes that experience ocular symptoms or complaints was reported for the 7- and 30-Day follow-up. | 7-Day Follow-up and 30-Day Follow-up | 
| Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining | Corneal staining was analyzed using the FDA grading scale (ie, Grade 0 = None, Grade 1 = Trace, Grade 2 = Mild, Grade 3 = Moderate and Grade 4 = Severe). These responses were categorized into a binary outcome as 1 if any Grade 2 or higher corneal staining was observed or otherwise 0 is recorded. Subjects with multiple events were counted only once for the analysis purpose. | 7-Day Follow-up and 30-Day Follow-up | 
| Change From Baseline Ocular Vision (7-Day) | Subjective overall ocular vision was assessed at baseline, dispensing and 7-Day follow-up using a Visual Analogue Scale (VAS) from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular vision score was calculated as 7-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline vision scores indicates better performance. The average change from baseline vision score for each Arm was report. | Baseline and 7 Day-Day Follow-up | 
| Change From Baseline Ocular Vision (30-Day) | Subjective overall ocular vision was assessed at baseline, dispensing and 30 Day follow-up using a Visual Analogue Scale (VAS) from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular vision score was calculated as 30-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline vision scores indicates better performance. The average change from baseline vision score for each Arm was report. | Baseline and 30 Day Follow-up |