Clinical Performance Evaluation of Two Silicone Hydrogel Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

Treatments: Device: CONTROL Contact Lens; Device: TEST Contact Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT02756078

CR-5816

Details and patient eligibility

About

This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type.

Enrollment: 200 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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 between 18 and 40 years of age.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -8.00 D in each eye.
• The subject's refractive cylinder must be no more than -1.00 D cylindrical correction in each eye after vertexing to the corneal plane.
• The subject must have best corrected visual acuity of 0.20 or better in each eye.
• The subject must be a current wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
• The subject must be using digital devices (any combination of computers, tablets, smart phones etc.) for at least 8 hours over the course of a typical day.
• The subject should own a wearable pair of spectacles and wear them the day of the baseline visit.
• The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
• The subject must meet normal eligibility conditions of binocular vision tests.
• The subject may not have any double vision at near with their habitual contact lens correction.

Exclusion criteria

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion).
• Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion).
• Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as a subject reporting headaches associated with birth control pills (at the investigator's discretion).
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
• Any active ocular infection.
• 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 interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
• Any known hypersensitivity or allergic reaction to the study products.
• 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.
• Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Group 1 (TEST / CONTROL wear sequence)

Active Comparator group

Description:

Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.

Treatment:

Device: TEST Contact Lens

Device: CONTROL Contact Lens

Group 2 (CONTROL / TEST wear sequence)

Active Comparator group

Description:

Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.

Treatment:

Device: TEST Contact Lens

Device: CONTROL Contact Lens