Clinical trial NCT02515994: Evaluation of a Johnson & Johnson Vision Care Investigational Contact Lens Compared to a Marketed Monthly Replacement Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-05
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-masked, controlled, 2-arm parallel group, multi-site, 3-month dispensing study of Johnson \& Johnson Vision Care, Inc. (JJVCI) Investigational contact lens, compared with a marketed, monthly replacement contact lens. Subjects will wear the JJVCI investigational contact lenses on a daily wear basis.

Detailed description: Objective of the study is to demonstrate the safety and efficacy of the JJVCI investigational contact lens by comparison to the marketed, monthly replacement contact lens, both worn for thirty days on a daily wear modality.

Eligibility criteria: Inclusion Criteria:

* The subject must read, understand, 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 years of age.
* The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
* The subject's refractive cylinder must be ≤ 1.00 Diopters in each eye.
* The subject must have best corrected visual acuity of 20/25 or better in each eye.
* Subjects should own a wearable pair of spectacles.
* The subject must be an adapted frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
* The subject must have normal eyes (i.e., no ocular medications or infections of any type).
* Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 4 days per week

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, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
* Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. Seldane, Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.
* 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 2 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 known hypersensitivity or allergic reaction to Optifree®Puremoist® multi-purpose care solution or Eye-Cept® rewetting drop solution
* Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Daily disposables, extended wear, monovision or multi-focal contact lens correction.
* Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
* History of binocular vision abnormality or strabismus.
* Employee or relative of employees of sponsor or investigational clinic (e.g., Investigator, Coordinator, Technician)

Primary outcomes:
measure: Slit Lamp Findings
timeFrame: Up to 3 Month Follow-up
measure: Visual Acuity
timeFrame: Up to 3 month Follow-up
Secondary outcomes:
measure: Symptoms
timeFrame: Up to 3 month Follow-up
measure: Average Wear Time
timeFrame: 3 month Follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Vue Optical Boutique
state: Florida
city: Longwood
country: United States
facility: Omega Vision Center, PA / Sabal Eye Care
state: Florida
city: Bloomington
country: United States
facility: Eyecare Associates
state: Illinois
city: Broadway Pittsburg
country: United States
facility: Advantage Eyecare Associates, LLC
state: Kansas
city: Closter
country: United States
facility: Dr. Debbie H. Kim, OD
state: New Jersey
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Pickens
country: United States
facility: Pickens Family Eye Care
state: South Carolina
city: Amarillo
country: United States
facility: Premier Vision
state: Texas
city: Salt Lake City
country: United States
facility: William J. Bogus OD
state: Utah
city: Salem
country: United States
facility: Timothy R. Poling, OD
state: Virginia
Study officials:
References: