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OpenTrials
Completed

NCT Number: NCT02699593

Clinical Evaluation of Approved Contact Lenses

This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

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 (including 70).
  • The subject's refractive cylinder must be < 0.75 Diopters (D) in each eye.
  • The subject must have best corrected visual acuity of 20/25 or better in each eye.
  • The subject must be a habitual and adapted wearer of ACUVUE® OASYS® brand contact lens in both eyes (at least 1 month of daily wear).
  • 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 -1.00 D to -6.00 D 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.
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (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

TEST Contact Lens

Device

Other names: senofilcon A made with material from a new supplier

CONTROL Contact Lens

Device

Other names: senofilcon A made with material from the current supplier

Primary outcomes

  1. Contact Lens Wearing Time

    Time frame: 2-week follow-up

    Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.

  2. Visual Acuity (LogMAR)

    Time frame: 2-week Follow-up

    Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2016
Registry last updated
Jul 12, 2017

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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