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

CR-6371

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

2020-09-16

2020-10-10

2020-10-10

Completed

Early phase I

32

Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Between 18 and 69 (inclusive) years of age at the time of screening. 4. Subjects must be habitual spherical soft contact lens wearers. 5. 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: 1. Currently pregnant or breast-feeding. 2. Diabetes. 3. Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the discretion of the investigator). 4. Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the discretion of the investigator). 5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report. 6. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK) 7. Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment. 8. History of binocular vision abnormality or strabismus. 9. 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. 10. 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) 11. Employees of investigational clinic (investigator, coordinator, and technician etc) or family members of an employee of the clinical site by self-report. 12. 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. 13. Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc.). 14. 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).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

2023-11-14