Status:
COMPLETED
Evaluation of Approved and Investigational Contact Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Acuity
Eligibility:
All Genders
18-49 years
Phase:
NA
Brief Summary
This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover, dispensing clinical trial. During the study, each test article will be worn in a daily wear modality for at least ...
Eligibility Criteria
Inclusion
- Potential subjects must satisfy all of the following inclusion criteria to be enrolled in the study:
- The subject must read and sign the Informed Consent form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Healthy adult males or females age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 6.00 Diopter (D).
- The subject's refractive cylinder must be ≤ 1.00D in each eye.
- The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
- Subjects must own a wearable pair of spectacles.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of Daily Wear per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
- Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- 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., 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.
- Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), 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 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.
- Toric, 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.
- Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).
Key Trial Info
Start Date :
July 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2017
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT03228212
Start Date
July 14 2017
End Date
September 18 2017
Last Update
December 13 2018
Active Locations (5)
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1
Dr. James Weber & Associates, PA
Jacksonville, Florida, United States, 32205
2
Vue Optical Boutique
Jacksonville, Florida, United States, 32250
3
VisionCare Associates
East Lansing, Michigan, United States, 48823
4
Pickens Family Eye Care
Pickens, South Carolina, United States, 29671