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OpenTrials
Completed

NCT Number: NCT01951703

Senofilcon A Investigational Manufacturing Process

To evaluate the impact of a new contact lens hydration process

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jacksonville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Senofilcon A

Device

Control, senfilcon A

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Official study title

Clinical Investigation of Senofilcon A Manufactured Using an Alternate Hydration Process

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 27, 2013
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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