Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-fit Into Senofilcon A Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01990664
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : February 25, 2016
Last Update Posted : June 19, 2018
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This study is an open-label, multi-site study. The total number of subjects was 200. The duration of this study was approximately four weeks. The primary objective was to assess what percentage of lapsed contact wearers, who have discontinued use of their contact lenses for greater than six months can be successfully re-fit with senofilcon A, reusable 2-weekly replacement daily wear lenses (spherical and toric designs).

Condition or disease Intervention/treatment Phase
Lapsed Contact Lens Wear Device: senofilcon A Device: senofilcon A for Astigmatism Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-Fit Into Spherical or Toric Senofilcon A Contact Lenses
Study Start Date : November 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: senofilcon A
Contact lenses to be worn in a daily wear modality
Device: senofilcon A
Experimental: senofilcon A for Astigmatism
Contact lenses to be worn in a daily wear modality
Device: senofilcon A for Astigmatism

Primary Outcome Measures :
  1. Proportion of Successfully Re-fitted Subjects [ Time Frame: 4 weeks ]
    Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 interested in wearing contact lenses.
  4. The subject must be at least 18 years old or less than 40 years of age at the time of consent.
  5. The subject's vertexed spherical cylindrical refraction must result in a contact lens prescription for each eye that is available in the investigator's choice of study contact lens material(s).
  6. The subject must have best corrected visual acuity of 20/30 or better in each eye.
  7. The subject must require visual correction in both eyes.
  8. The subject must be a lapsed wearer (defined as, any non-contact lens wearer requiring optical correction who has been previously fitted in and has previously purchased contact lenses but has since discontinued contact lens wear for any reason more than 6 months prior to the time of consent).
  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. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
  5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.)
  6. 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 tha may contraindicate contact lens wear.
  7. Any ocular infection.
  8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  9. Participation in any contact lens or lens care trial within one year prior to study enrollment.
  10. History of binocular vision abnormality or strabismus.
  11. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g., HIV), by self report.
  12. Employee of the investigational clinic (i.e., Investigator, Coordinator, or Technician).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01990664

United States, Florida
Jacksonville, Florida, United States, 32205
Saint Augustine, Florida, United States, 32092
Sarasota, Florida, United States, 34232
United States, Georgia
Roswell, Georgia, United States, 30076
United States, Illinois
Bloomington, Illinois, United States, 61701
United States, Missouri
Raytown, Missouri, United States, 60415
United States, New York
Vestal, New York, United States, 13850
United States, North Carolina
Raleigh, North Carolina, United States, 27615
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Responsible Party: Johnson & Johnson Vision Care, Inc. Identifier: NCT01990664     History of Changes
Other Study ID Numbers: CR-5464
First Posted: November 21, 2013    Key Record Dates
Results First Posted: February 25, 2016
Last Update Posted: June 19, 2018
Last Verified: January 2016