N/A
N=168
A Clinical Trial to Evaluate Investigational Silicone Hydrogel Contact Lenses Worn Continuously for One Week
Visual Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02543528 ↗Enrolled (actual)
168
Serious AEs
1.3%
Results posted
Mar 2018
Primary outcome: Primary: Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) — 14; 13; 12; 1 Number of Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational Lens 1 (Device); Investigational Lens 2 (Device); Investigational Lens 3 (Device); etafilcon A (Reusable) (Device); etafilcon A (1-Day) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) |
14; 13; 12; 1 | — |
| SECONDARY Overall Comfort Score |
59.39; 60.22; 58.85; 62.51; 58.38; 60.12 | — |
| SECONDARY Overall Vision Score |
55.27; 56.78; 52.87; 60.28; 53.02; 54.66 | — |
Summary
This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. The study has a total of 9 scheduled study visits and a total duration of ~197 days. The lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.
Eligibility Criteria
Inclusion Criteria
- The subject must read and understand English and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be at least 18 and no more than 39 years of age.
- The subject's spherical equivalent distance refraction must be in the range of -1.00 to -5.50 diopters in each eye.
- The subject's refractive cylinder must be less than 1.00 diopters in each eye.
- The subject must have best corrected visual acuity of 20/30 or better in each eye.
- The subject must be without history of contact lens use in the past 12 months.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion Criteria
- Any previous experience wearing contact lenses on an overnight or extended wear basis (at least 1 night per month)
- Currently pregnant or lactating (self reported) (subjects who become pregnant during the study will be discontinued).
- Currently a regular smoker (1 or more times per month).
- Current routine swimmer (1 or more times per month).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease (ex. Sjögren's Syndrome), autoimmune disease (ex. rheumatoid arthritis), or use of medication (ex. chronic steroid use), which may interfere with contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
- Any previous or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), etc.).
- 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.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Participation in any contact lens or lens care product clinical trial within 7 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).
- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
Data sourced from ClinicalTrials.gov (NCT02543528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.