Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of Investigational Lubricating Eye Drops
Overview
- Phase
- Phase 2
- Intervention
- Blink® Tears eye drops in a multidose bottle
- Conditions
- Visual Acuity
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 46
- Locations
- 3
- Primary Endpoint
- Monocular logMAR Visual Acuity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This will be a single-visit, multi-site, randomized, single-masked, bilateral, active-controlled, non-dispensing, 2X2 crossover study.
Investigators
Eligibility Criteria
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).
Arms & Interventions
Test/Control
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.
Intervention: Blink® Tears eye drops in a multidose bottle
Test/Control
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.
Intervention: Preservative-free investigational lubricating eye drops in a Novelia® eyedropper
Control/Test
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.
Intervention: Blink® Tears eye drops in a multidose bottle
Control/Test
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.
Intervention: Preservative-free investigational lubricating eye drops in a Novelia® eyedropper
Outcomes
Primary Outcomes
Monocular logMAR Visual Acuity
Time Frame: 10 Minutes Post Eye Drop Administration
Monocular visual acuity was measured at distance (4meter) using a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast lighting conditions. VA was assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual acuity score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.