Mode
Text Size
Log in / Sign up
N/A N=127 Randomized Double-blind Supportive Care

Senofilcon A Investigational Manufacturing Process

Visual Acuity · Comfort · Overall Vision

Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Subjective Overall Comfort (Using CLUE ) — 63.3; 65.0 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
senofilcon A (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Dec 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Subjective Overall Comfort (Using CLUE )
63.3; 65.0
PRIMARY
Subjective Overall Vision (Using CLUE )
65.2; 65.2

Summary

To evaluate the impact of a new contact lens hydration process

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 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01951703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search