Senofilcon A Investigational Manufacturing Process

Clinical Investigation of Senofilcon A Manufactured Using an Alternate Hydration Process

To evaluate the impact of a new contact lens hydration process

Study Overview

• Status: Completed
• Conditions: Visual Acuity; Comfort; Overall Vision
• Intervention / Treatment: Device: senofilcon A; Device: senofilcon A

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
  • Illinois
    • Bloomington, Illinois, United States, 61701
  • Kansas
    • Pittsburg, Kansas, United States, 66762
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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; Device: senofilcon A; Test, senofilcon 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; Control, senfilcon A; Device: senofilcon A; Test, senofilcon A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Overall Comfort (Using CLUE )	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 weeks
Subjective Overall Vision (Using CLUE )	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.	2 weeks

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Brian Pall, OD, Johnson & Johnson Vision Care

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimate): September 27, 2013

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CR-5509