Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Overall Vision Score
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
- •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 of investigational clinic (e.g., Investigator, Coordinator, Technician).
Arms & Interventions
CONTROL- etafilcon A current molding
1-Day ACUVUE® MOIST
Intervention: Test/Control (Device)
CONTROL- etafilcon A current molding
1-Day ACUVUE® MOIST
Intervention: Control/Test (Device)
TEST- etafilcon A novel molding
Investigational Contact Lens
Intervention: Test/Control (Device)
TEST- etafilcon A novel molding
Investigational Contact Lens
Intervention: Control/Test (Device)
Outcomes
Primary Outcomes
Overall Vision Score
Time Frame: 1-Week Follow-up
Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Overall Comfort Scores
Time Frame: 1-Week Follow-up
Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Secondary Outcomes
No secondary outcomes reported