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

NCT01990664 | Completed Results

• 1 other identifier: CR-5464
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 10

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).

Conditions

Lapsed Contact Lens Wear

Outcome Measures

Primary Outcomes (1)

• Proportion of Successfully Re-fitted Subjects

  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.

  4 weeks

Study Arms (2)

senofilcon A

EXPERIMENTAL

Contact lenses to be worn in a daily wear modality

Device: senofilcon A

senofilcon A for Astigmatism

EXPERIMENTAL

Contact lenses to be worn in a daily wear modality

Device: senofilcon A for Astigmatism

Interventions

senofilcon A DEVICE

senofilcon A

senofilcon A for Astigmatism DEVICE

senofilcon A for Astigmatism

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 interested in wearing contact lenses.
• The subject must be at least 18 years old or less than 40 years of age at the time of consent.
• 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).
• The subject must have best corrected visual acuity of 20/30 or better in each eye.
• The subject must require visual correction in both eyes.
• 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).
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).

You may not qualify if:

• 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, which 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.
• Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (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 tha may contraindicate contact lens wear.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Participation in any contact lens or lens care trial within one year prior to study enrollment.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g., HIV), by self report.
• Employee of the investigational clinic (i.e., Investigator, Coordinator, or Technician).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (10)

Unknown Facility

Jacksonville, Florida, 32205, United States

Location

Unknown Facility

Saint Augustine, Florida, 32092, United States

Location

Unknown Facility

Sarasota, Florida, 34232, United States

Location

Unknown Facility

Roswell, Georgia, 30076, United States

Location

Unknown Facility

Bloomington, Illinois, 61701, United States

Location

Unknown Facility

Raytown, Missouri, 60415, United States

Location

Unknown Facility

Vestal, New York, 13850, United States

Location

Unknown Facility

Raleigh, North Carolina, 27615, United States

Location

Unknown Facility

Warwick, Rhode Island, 02886, United States

Location

Unknown Facility

Memphis, Tennessee, 38119, United States

Location

Results Point of Contact

• Title: Jurandir Araujo, Clinical Compliance Manager
• Organization: Johnson & Johnson Vision Care, Inc.

jaraujo7@its.jnj.com

9044431379

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 19, 2018
• Results First Posted: February 25, 2016

Record last verified: 2016-01

Locations

US (10)