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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01990664
First received: November 15, 2013
Last updated: January 28, 2016
Last verified: January 2016
  Purpose
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 Intervention
Lapsed Contact Lens Wear
Device: senofilcon A
Device: senofilcon A for Astigmatism

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Proportion of Successfully Re-fitted Subjects [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 199
Study Start Date: November 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990664

Locations
United States, Florida
Jacksonville, Florida, United States, 32205
Sarasota, Florida, United States, 34232
St. Augustine, Florida, United States, 32092
United States, Georgia
Roswell, Georgia, United States, 30076
United States, Illinois
Bloomington, Illinois, United States, 61701
United States, Missouri
Ray Town, 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.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01990664     History of Changes
Other Study ID Numbers: CR-5464 
Study First Received: November 15, 2013
Results First Received: December 21, 2015
Last Updated: January 28, 2016
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on December 06, 2016