Clinical trial NCT02543528: A Clinical Trial to Evaluate Investigational Silicone Hydrogel Contact Lenses Worn Continuously for One Week
Official title: Echo Ionic Silicone Hydrogel 6-Month Extended Wear Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Disorder
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Primary outcomes:
measure: Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Overall Comfort Score
timeFrame: Time Frame Up to 6 months
measure: Overall Vision Score
timeFrame: Time Frame Up to 6 months
Other outcomes:
Locations:
city: Chennai
country: India
facility: Medical Research Foundation, Sankara Nethralaya
Study officials:
References: