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OpenTrials
Completed

NCT Number: NCT02760810

Clinical Evaluation of An Approved Contact Lens

This is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users over a 14-day period.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aston University

Birmingham, West Midlands, B4 7ET, United Kingdom

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 between 18 and 45 years of age.
  • The subject must have a valid spectacle prescription with expiration date not over 1 year.
  • The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.25 Diopters (D) to -6.00 D in each eye.
  • The subject's refractive cylinder must be ≤1.00 Cylindrical Diopter (DC) in each eye.
  • The subject must have best corrected visual acuity of logMAR 0.20 or better in each eye.
  • Subjects should own a wearable pair of spectacles and agree to wear them the day of the initial visit and every morning on subsequent visit days.
  • The subject must be a contact lens neophyte, defined as never having been dispensed contact lenses, or who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses.
  • The subject must have normal eyes (i.e. no ocular medications or infections of any type).

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, which may interfere with contact lens wear.
  • Use of any medication with known tear film effects within 2 weeks prior to and during the study.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion..
  • 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 ocular infection.
  • Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  • Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).

Treatment and study plan

Marketed Contact Lens

Device

Narafilcon A

Primary outcomes

  1. Tear Film Osmolarity

    Time frame: 2-Week Follow-up

    Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing

Secondary outcomes

  1. Tear Film Osmolarity

    Time frame: 1-Week Follow-up

    Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing.

  2. Tear Film PH

    Time frame: 1-Week Follow-up

    Tear Film PH was measured using a 1mm Microglass electrode (Thermo Scientific Orion 9810BN) placed gently in lower temporal tear meniscus of non-Schirmer eye without simulating reflex tearing.

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
May 4, 2016
Registry last updated
Jul 11, 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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