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OpenTrials
Completed

NCT Number: NCT02365298

Clinical and Laboratory Study of Lysozyme Deposition on Daily Disposable Contact Lenses

In vitro studies show that some hydrogel materials uptake more lysozyme than other hydrogel materials and that this protein remains largely active and promotes reduced cytokine response in an in vitro culture of human corneal epithelial cells. This study investigates whether these data transfer to the in vivo situation.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

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 the clinical protocol.
  • The subject must be willing to follow instructions and maintain the appointment schedule.
  • The subject must be between 18 and 40 years of age (inclusive).
  • The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50D to -6.00D in each eye (inclusive).
  • The subject's refractive cylinder must not exceed -1.25DC in each eye after vertexing to the corneal plane.
  • The subject must be a current wearer of spherical, soft contact lenses (no toric, bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during to month prior to enrollment.
  • The subject must own a wearable pair of spectacles and wear them the day of the initial visit.
  • The subject must be an existing wearer of spherical soft contact lenses in both eyes.
  • The subject must have normal eye (i.e., no ocular medications or infections of any type).
  • The subject must be able to wear the study lenses for a minimum seven hours per day.

Exclusion criteria

  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion).
  • Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion).
  • Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  • Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
  • Any active ocular infection.
  • Is using any topical medication including artificial tears (ATS) up to two weeks prior to the screening visit.
  • Any participants whose habitual contact lenses are used as an extended wear regimen.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear; clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any know hypersensitivity or allergic reaction to study products.
  • Participation in any contact lens or lens care product clinical trial within seven days prior to study enrollment.
  • Employee or family member of the Center for Contact Lens Research (e.g., Investigator, Coordinator, Technician).

Treatment and study plan

etafilcon A

Device

etafilcon A soft contact lens

Other names: Marketed Investigational Soft Contact Lens

Nelfilcon A

Device

nelfilcon A

Other names: Marketed Investigational Soft Contact Lens

Primary outcomes

  1. Total Protein and Total Lysosome Deposits

    Time frame: 2 wks after baseline

    Measurement will be taken after the subject has worn the lenses for a full seven hours

  2. Total Protein and Total Lysosome Deposits

    Time frame: 6 wks after baseline

    Measurement will be taken after the subject has worn the lenses for a full seven hours

  3. Total Protein and Lysosome Deposits

    Time frame: 12 wks after baseline

    Measurement will be taken after the subject has worn the lenses for a full seven hours

  4. Quantity of Cytokines and Albumin in Tear Fluid

    Time frame: 2 wks after baseline

    Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha Measurement will be taken after the subject has worn the lenses for a full seven hours.

  5. Quantity of Cytokines and Albumin in Tear Fluid

    Time frame: 6 wks after baseline

    Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.

  6. Quantity of Cytokines and Albumin in Tear Fluid

    Time frame: 12 wks after baseline

    Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2015
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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