Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of a Lipid- Based Lubricating Eye Drop

Study Overview
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Brief Summary
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This is a single visit, randomized, double masked, bilateral, non-dispensing, 2×2 crossover study to assess visual acuity.

Official Title
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Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of a Lipid- Based Lubricating Eye Drop

Conditions
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Visual Acuity

Intervention / Treatment
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* Drug: Blink® Tears eye drops
* Drug: Investigational lipid 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: 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. Between 18 and 69 (inclusive) years of age at the time of screening. Subjects must be habitual spherical soft contact lens wearers. 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: Currently pregnant or breast-feeding. Diabetes. Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the discretion of the investigator). Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the discretion of the investigator). Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK) Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment. History of binocular vision abnormality or strabismus. Habitual wearers of rigid gas permeable lens within the past 3 months5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months. Current habitual use of Prescription Medication 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 members of an employee of the clinical site by self-report. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, cornea vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification 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.\ In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain should not participate in the study (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).

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: Double


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 the TEST lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the CONTROL lubricating eye drops will be instilled. | Drug: Blink® Tears eye drops<br>* Control Drops<br>Drug: Investigational lipid eye drops<br>* Test Drops<br>|
| Experimental: Control/Test<br>Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the CONTROL lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the TEST lubricating eye drops will be instilled. | Drug: Blink® Tears eye drops<br>* Control Drops<br>Drug: Investigational lipid eye drops<br>* Test Drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LogMAR visual acuity | Change in logMAR visual acuity after the instillation of a lipid-based eye drop under high luminance (120 - 200 cd/m2) low contrast (<2.5 lux) (HLLC) at distance (4 meters). | 3-minutes post instillation of eye drops | 
| LogMAR visual acuity | Change in logMAR visual acuity after the instillation of a lipid-based eye drop under high luminance (120 - 200 cd/m2) low contrast (<2.5 lux) (HLLC) at distance (4 meters). | 10-minutes post instillation of eye drops |