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Senofilcon A Investigational Manufacturing Process

Johnson & Johnson (J&J) logo

Johnson & Johnson (J&J)

Status

Completed

Conditions

Overall Vision
Comfort
Visual Acuity

Treatments

Device: senofilcon A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01951703
CR-5509

Details and patient eligibility

About

To evaluate the impact of a new contact lens hydration process

Full description

To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an alternate hydration process and compare the performance with senofilcon A lenses manufactured using the current process.

Enrollment

136 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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 at least 18 and not more than 70 years of age.
  • The subject's refractive cylinder must be < 0.75D in each eye.
  • The subject must have best corrected visual acuity of 20/25 or better in each eye.
  • The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the study contact lenses.
  • The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes.
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  • The subject's required spherical contact lens prescription must be in the range of -0.50 to -9.00D in each eye.

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.
  • Any systemic disease, autoimmune disease, or use of medication, that 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, 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 OPTI-FREE® PureMoist® Contact Lens Solution.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Monovision or multi-focal contact lens correction.
  • Participation in any contact lens or lens care product clinical trial within 14 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).
  • Suspicion of or recent history of alcohol or substance abuse.
  • History of serious mental illness.
  • History of seizures.
  • Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

136 participants in 2 patient groups

Control, senofilcon A
Active Comparator group
Description:
Subjects received Control lens, senofilcon A during the first two weeks of the study then Test lens, senofilcon A in the last two weeks of the study.
Treatment:
Device: senofilcon A
Device: senofilcon A
Test, senofilcon A
Experimental group
Description:
Subjects received Test lens, senofilcon A during the first two weeks of the study then Control lens, senofilcon A in the last two weeks of the study.
Treatment:
Device: senofilcon A
Device: senofilcon A

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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