Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 268
- Locations
- 12
- Primary Endpoint
- Overall Vision Scores
Study Overview
Brief Summary
This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older 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.
- •Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
- •The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- •The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.
- •The subject's refractive cylinder must be < 0.75 D in each eye.
- •The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion Criteria
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- •Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
- •Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Monovision or multi-focal contact lens correction.
- •Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
- •Suspicion of or recent history of alcohol or substance abuse.
- •History of serious mental illness.
- •History of seizures.
- •Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
- •Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- •Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale.
- •Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
Arms & Interventions
TEST/CONTROL
Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Test/Control sequence.
Intervention: etafilcon A with novel molding process (Device)
TEST/CONTROL
Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Test/Control sequence.
Intervention: etafilcon A with current molding process (Device)
CONTROL/TEST
Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Control/Test sequence.
Intervention: etafilcon A with novel molding process (Device)
CONTROL/TEST
Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Control/Test sequence.
Intervention: etafilcon A with current molding process (Device)
Outcomes
Primary Outcomes
Overall Vision Scores
Time Frame: 1-week Follow-up
Overall vision was assessed using the CLUE questionnaire. CLUE is a validated PRO questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using IRT follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Overall Comfort Scores
Time Frame: 1-week Follow-up
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Secondary Outcomes
- LLHC LogMAR Visual Performance(1-week Follow-up)
- Average Daily Wear Time(1-week Follow-up)
- HLLC LogMAR Visual Performance(1-week Follow-up)