Clinical Study of Approved and Investigational Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

Treatments: Device: Lotrafilcon B Contact Lens; Device: Senofilcon C Contact Lens; Device: Samfilcon A Contact Lens; Device: Comfilcon A Contact Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT02708524

CR-5808

Details and patient eligibility

About

This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational contact lens with currently-marketed contact lenses. The objective of the study is to evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.

Enrollment: 554 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 18 to 40 years of age at the time of consent.
4. The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye.
5. The subject's refractive cylinder must be ≤1.00D in each eye.
6. The subject must have best corrected visual acuity of 20/30 or better in each eye.
7. The subject must be a habitual frequent replacement (reusable) daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
8. The subject must be able to wear contact lenses for a minimum of 8 hours, 4 days per week.
9. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion criteria

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
5. Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction.
6. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
7. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
8. 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.
9. Any ocular infection.
10. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
12. History of binocular vision abnormality or strabismus.
13. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report).
14. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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554 participants in 4 patient groups

Senofilcon C Wearers

Experimental group

Description:

Senofilcon C Wearers will wear the Senofilcon C Contact Lenses as daily wear for 30 (-2/+6) days.

Treatment:

Device: Senofilcon C Contact Lens

Comfilcon A Wearers

Active Comparator group

Description:

Comfilcon A Wearers will wear the Comfilcon A Contact Lens as daily wear for 30 (-2/+6) days.

Treatment:

Device: Comfilcon A Contact Lens

Lotrafilcon B Wearers

Active Comparator group

Description:

Lotrafilcon B Wearers will wear the Lotrafilcon B Contact Lens as daily wear for 30 (-2/+6) days.

Treatment:

Device: Lotrafilcon B Contact Lens

Samfilcon A Wearers

Active Comparator group

Description:

Samfilcon A Wearers will wear the Samfilcon A Contact Lens as daily wear for 30 (-2/+6) days.

Treatment:

Device: Samfilcon A Contact Lens