Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 134
- Locations
- 12
- Primary Endpoint
- Long Lasting Comfort
Study Overview
Brief Summary
This is a prospective, multi-site, 4-visit, bilateral, dispensing, randomized, controlled, double-masked, 2x2 crossover study to evaluate subjective comfort, overall opinion and end of day comfort following wear of two different contact lenses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 39 (inclusive) years of age at the time of screening.
- •By self-report, habitually wear soft 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 of wear per day, for a minimum of 2 days per week during the past four weeks.
- •Possess a wearable pair of spectacles that provide correction for distance vision.
- •In both eyes, have refractive error suitable for correction with the range of toric contact lens powers available in this study:
- •6.1 Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps 6.2 Cylinder powers (DC) -0.75 and -1.25 6.3 Axes (°) 170, 180, 10, 80, 90 and 100
- •Have best corrected monocular distance visual acuity of 20/25 or better in each eye.
- •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.
- •By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, 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 6 months.
- •Be currently wearing monovision or multifocal contact lenses.
- •Be currently wearing lenses in an extended wear modality.
- •Have a history of strabismus or amblyopia.
- •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.
- •Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- •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 contact lens wear 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 fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- •Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
Exclusion Criteria
- Not provided
Arms & Interventions
Control/Test
Eligible subjects will be randomized into the Control/Test sequence, to wear each study lens (Control lens and Test lens) in a daily disposable modality for approximately one week with a washout period of one week between study lens wear periods.
Intervention: Test Lens (Device)
Control/Test
Eligible subjects will be randomized into the Control/Test sequence, to wear each study lens (Control lens and Test lens) in a daily disposable modality for approximately one week with a washout period of one week between study lens wear periods.
Intervention: Control Lens (Device)
Test/Control
Eligible subjects will be randomized into the Test/Control sequence, to wear each study lens (Test lens and Control lens) in a daily disposable modality for approximately one week with a washout period of one week between study lens wear periods.
Intervention: Test Lens (Device)
Test/Control
Eligible subjects will be randomized into the Test/Control sequence, to wear each study lens (Test lens and Control lens) in a daily disposable modality for approximately one week with a washout period of one week between study lens wear periods.
Intervention: Control Lens (Device)
Outcomes
Primary Outcomes
Long Lasting Comfort
Time Frame: 1-week Follow-up
Long lasting comfort, with respect to contact lens wear, was assessed using the individual questionnaire item: 'I could wear these contact lenses comfortably for as long as I wanted to'. This item utilized an agreement scale of, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Long lasting comfort was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Strongly Agree or Agree and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.
Secondary Outcomes
- Comfort at the End of the Day(1-Week Follow-up)
- Overall Opinion(1-Week Follow-up)