Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Senofilcon A Investigational Manufacturing Process

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.
 
ClinicalTrials.gov Identifier: NCT01951703
Recruitment Status : Completed
First Posted : September 27, 2013
Results First Posted : August 3, 2015
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
To evaluate the impact of a new contact lens hydration process

Condition or disease Intervention/treatment Phase
Visual Acuity Comfort Overall Vision Device: senofilcon A Not Applicable

Detailed Description:
To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an alternate hydration process and compare the performance with senofilcon A lenses manufactured using the current process.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Clinical Investigation of Senofilcon A Manufactured Using an Alternate Hydration Process
Study Start Date : September 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Active Comparator: Control, senofilcon A
Subjects received Control lens, senofilcon A during the first two weeks of the study then Test lens, senofilcon A in the last two weeks of the study.
Device: senofilcon A
Control, senfilcon A

Experimental: Test, senofilcon A
Subjects received Test lens, senofilcon A during the first two weeks of the study then Control lens, senofilcon A in the last two weeks of the study.
Device: senofilcon A
Test, senofilcon A




Primary Outcome Measures :
  1. Subjective Overall Comfort (Using CLUE ) [ Time Frame: 2 weeks ]
    Contact Lens User Experience Comfort scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

  2. Subjective Overall Vision (Using CLUE ) [ Time Frame: 2 weeks ]
    Contact Lens User Experience Vision scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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 ClinicalTrials.gov identifier (NCT number): NCT01951703


Locations
Layout table for location information
United States, Florida
Jacksonville, Florida, United States, 32256
United States, Illinois
Bloomington, Illinois, United States, 61701
United States, Kansas
Pittsburg, Kansas, United States, 66762
United States, Rhode Island
Warwick, Rhode Island, United States, 02888
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Investigators
Layout table for investigator information
Study Director: Brian Pall, OD Johnson & Johnson Vision Care

Layout table for additonal information
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01951703    
Other Study ID Numbers: CR-5509
First Posted: September 27, 2013    Key Record Dates
Results First Posted: August 3, 2015
Last Update Posted: June 19, 2018
Last Verified: April 2016