Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-fit Into Senofilcon A Contact Lenses (Phase 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01990664
First received: November 15, 2013
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

This study is an open-label, multi-site study, divided into two phases. The total number of subjects for phase one is 200. The duration of this phase of the study is approximately four weeks. The primary objective is 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.


Condition Intervention
Lapsed Contact Lens Wear
Device: senofilcon A
Device: senofilcon A for Astigmatism

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 (Phase 1)

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Successfully Re-fitted Subjects [ Time Frame: Percentageof subjects completed use for 4 weeks ] [ Designated as safety issue: No ]
    A re-fit is considered successful based on eye care professional judgement of acceptable physiology, comfort, vision and handling to continue further contact lens wear.


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
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, 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
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01990664     History of Changes
Other Study ID Numbers: CR-5464 (Phase 1)
Study First Received: November 15, 2013
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 29, 2014