Clinical Evaluation of a Multidose Preservative-free Lubricating Eye Drops Contained in Novelia® Eye Dropper in Non-Contact Lens Wearing Patients

Study Overview
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Brief Summary
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This is a 30-Day, multi-site, single-masked, bilateral, active- controlled, 2-Arm parallel group study to evaluate the safety and efficacy of an Investigational product.

Official Title
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Clinical Evaluation of a Multidose Preservative-free Lubricating Eye Drops Contained in Novelia® Eye Dropper in Non-Contact Lens Wearing Patients

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Investigational Lubricating Eye Drop in a Novelia® bottle
* Drug: Blink® Tears eye Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. Appear able and willing to adhere to the instructions set forth in this clinical protocol. Be between 18 and 69 (inclusive) years of age at the time of screening. Possess a wearable pair of spectacles that provide correction for distance vision and bring them to every visit (only if applicable- to the investigator's discretion). Self-reported symptoms of ocular dryness and/or the use of artificial tears in the last 3 months. Subjects must be non-contact lens wearers. The best corrected, monocular, distance visual acuity must be 20/30 or better in each eye, either unaided or best corrected. Exclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: Be currently pregnant or lactating. Be diabetic. Be currently using any ocular medications or have any ocular infection of any type which may interfere with the clinical trial (at the investigator's discretion). By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with the clinical trial, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 3 months and soft contact lenses in the past 1 month. Have participated in any pharmaceutical or medical device related clinical trial within 30 days prior to study enrollment. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. Be a current habitual user of prescription medication to treat dry eye and ocular discomfort, ocular steroids, or any medication (RX or OTC), except for artificial tears that would interfere with the clinical study (at the discretion of the investigator). Have any known allergy or sensitivity to ingredients that the investigational product may contain (e.g., Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate and Purified Water). Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities, or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate participation or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). Have a history of strabismus or amblyopia. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, cataract removal, retinal laser photocoagulation, etc.). Have any significant corneal distortion due to previous contact lens wear, surgery, or pathology (At the discretion of the investigator).

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational product<br>Eligible subjects will be randomly assigned the investigational product to be used in both eyes for the duration of the study. | Drug: Investigational Lubricating Eye Drop in a Novelia® bottle<br>* Investigational Product<br>|
| Active Comparator: Control product<br>Eligible subjects will be randomly assigned the control product to be used in both eyes for the duration of the study | Drug: Blink® Tears eye Drops<br>* Control Product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Overall Comfort | Subjective overall ocular comfort will be assessed using a Visual Analogue Scale (VAS) with continuous scale from 0 (Extremely uncomfortable) to 100 (Extremely comfortable). | Up to 30-day follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Overall Quality of Vision | Change in quality of vision from baseline will be assessed using Visual Analogue Scale (VAS) with continuous scale from 0 (Extremely uncomfortable) to 100 (Extremely comfortable). | Up to 30-Day follow up |