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OpenTrials
Completed

NCT Number: NCT01819194

Contact Lens Comfort Relative to Meibomian Gland Status

This trial aims to establish a correlation between patient reported comfort while using soft contact lenses and meibomian gland dysfunction (MGD).

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fullerton, California, 92831, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The subject must be able to read, understand, and sign the statement of informed consent and receive a fully executed copy of the form.
  • The subject be able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must be 18 and less than 39 years of age.
  • The subject must be an adapted soft contact lens wearer in both eyes (Defined as having been a full times lens wearer for at least 3 months).
  • Subjects must be current full time daily wearers of Acuvue Oasys lenses (defined as, at least 6 hours per day, 5 days per week).
  • The subject's spherical equivalent distance refraction must be in the range of 0.00 to -6.00D in each eye.
  • The subject must present at visit 1 with a current copy of their spectacle prescription.
  • The subject must have the best corrected visual acuity of 0.18 or better in each eye as assessed by LogMAR chart.
  • The subject must have normal eyes (i.e., no ocular medication, or infections of any type)

Exclusion criteria

  • Wear Acuvue Oasys with Hydraclear Plus on an extended wear basis.
  • Wear Acuvue Oasys with Hydraclear Plus for astigmatism.
  • History of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva; mycobacterial infection of the eye; and/or fungal disease of the eye.
  • Use of concomitant ocular medications during the study period. Topical artificial tears or contact lens lubricants are allowed, but no instillation on the day of examinations.
  • Any systemic disease, autoimmune disease, or use of medications, which may interfere with contact lens wear.
  • Subjects using medications influencing tear production such as steroids, immunosuppressive agents and/or anti-cholinergics (e.g. cold and allergy medications, tricyclic antidepressants) for treatment of autoimmune connective tissue disease may not be enrolled in this study if they have not been on a stable dosing regimen for 30 days prior to the Eligibility Visit. Subjects may use birth control medications since there is inconclusive evidence relative to the influence on tear film.
  • Any infectious disease (e.g. Hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV, by self report).
  • Subjects reporting discomfort at screening visit related to fit or care system abnormalities (both determined by the investigator), ocular conditions such as conjunctival infections, iritis.
  • 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.
  • Entropion, ectropion, extrusion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosion,aphakia, or moderate or above corneal distortion by keratometry.
  • Any previous, or planned, ocular or intraocular surgery (radial keratotomy, 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 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 30 days prior to study enrollment
  • History of binocular vision abnormality or strabismus
  • History of serious mental illness
  • History of seizures

Treatment and study plan

Senofilcon A

Device

Primary outcomes

  1. Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)

    Time frame: Post 3 days of wear

    CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.

  2. Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale

    Time frame: Post 3 days of wear

    Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 - 11 scale translated into grades 0 to 3 where 0 refers to absence of markers.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 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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