Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of Investigational Lubricating Eye Drops

Study Overview
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Brief Summary
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This will be a single-visit, multi-site, randomized, single-masked, bilateral, active-controlled, non-dispensing, 2X2 crossover study.

Official Title
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Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of Investigational Lubricating Eye Drops

Conditions
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Visual Acuity

Intervention / Treatment
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* Drug: Blink® Tears eye drops in a multidose bottle
* Drug: Preservative-free investigational lubricating eye drops in a Novelia® eyedropper


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: The subject must: 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. By self-report, habitually wear soft spherical contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wear is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the last 30 days. Subjects must achieve visual acuity of 20/30 or better in each eye, with their habitual contact lenses. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: The subject must not: 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. Have participated in any pharmaceutical or medical device related clinical trial within 14 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 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test/Control<br>Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (test then control). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated. | Drug: Blink® Tears eye drops in a multidose bottle<br>* Control<br>Drug: Preservative-free investigational lubricating eye drops in a Novelia® eyedropper<br>* Test<br>|
| Experimental: Control/Test<br>Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (control then test). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated. | Drug: Blink® Tears eye drops in a multidose bottle<br>* Control<br>Drug: Preservative-free investigational lubricating eye drops in a Novelia® eyedropper<br>* Test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular distance (4 m) High Luminance, Low Contrast (HLLC) logMAR visual acuity under high illumination | Monocular distance logMAR visual acuity will be measured at distance 4 meters under high luminance (7.3 - 7.9 EV (394-597 lux)) and low contrast (10.5 -10.7 EV (181-208cd/m2)) conditions | Up to 10 minutes post instillation of eyedrop |