NCT01386008TerminatedNot Applicable
Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Coopervision, Inc.
- Enrollment
- 28
- Locations
- 4
- Primary Endpoint
- Ocular Health
Study Overview
Brief Summary
The purpose of this study is to evaluate the performance of the investigational CooperVision silicone hydrogel lens compared to a currently-marketed silicone hydrogel contact lens up to 30 days of daily lens wear.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be at least 18 years of age as of the date of evaluation for the study.
- •Not using any ocular medications
- •Have a self-reported full eye examination within 2 years.
- •read the Informed Consent
- •be given an explanation of the Informed Consent
- •indicate understanding of the Informed Consent
- •signed the Informed Consent document.
- •Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- •Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
- •Possess wearable and visually functional eyeglasses.
- •Be in good general health, based on his/her knowledge.
- •Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 0.75 diopter of refractive astigmatism in order to have the best spherical equivalent power of -6.50 or less.
- •Be willing to wear contact lenses in both eyes.
- •Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 (less than or equal to LogMAR 0.10) in each eye.
- •Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.
Exclusion Criteria
- •Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
- •Any active participation in another one-day clinical trial within 7 days prior to this study or another dispensing trial within 30 days prior to this study.
- •Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next month.
- •Has a known sensitivity to ingredients used in the over the counter contact lens care approved for use in the study.
- •Previous refractive surgery/anterior segment surgery; or current or previous orthokeratology treatment or irregular cornea.
- •Is aphakic or pseudophakic.
- •Unable to achieve a satisfactory fit with the lens designs used in the study
- •Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
- •The need for topical ocular medications or any medication which might contradict contact lens wear or which would require the lenses to be removed during the day.
- •The presence of clinically anterior segment infection, inflammations or abnormalities; such as iritis; or any infection of the eye, lids, or associated structures.
- •A history of herpetic keratitis.
- •A known history of corneal hypoesthesia (reduced corneal sensitivity) or active corneal ulcer, corneal infiltrates or fungal infection.
- •A history of papillary conjunctivitis that has interfered with contact lens wear.
- •Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- •Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > grade 2
- •Pterygium
- •Corneal scars within the visual axis
- •Corneal edema or corneal staining ≥ grade 2
- •Neovascularization or ghost vessels > 1.0 mm in from the limbus
- •Giant papillary conjunctivitis (GPC) of > grade
- •Seborrheic eczema, seborrheic conjunctivitis or blepharitis
Arms & Interventions
enfilcon A + senofilcon A
Other
Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
Intervention: senfilcon A contact lens (Device)
enfilcon A + senofilcon A
Other
Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
Intervention: investigational enfilcon A (Device)
Outcomes
Primary Outcomes
Ocular Health
Time Frame: Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.
Subjective Comfort Preference - Participants Preference Response
Time Frame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.
Secondary Outcomes
- Investigator Surface Preference(V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30))
- Investigator Fit Preference(V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30))
Investigators
Study Sites (4)
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