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OpenTrials
Completed

NCT Number: NCT02349438

Assessment of Contact Lens Wettability Using Wavefront Aberrometry

This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.

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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

Kelvin Grove, Queensland, 4059, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males or females that are at least 18 to no more than 40 years of age.
  • 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 possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision.
  • The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of lens wear per week for a minimum of 1 month prior to the study) or has sufficient prior experience with soft contact lens wear (defined as a minimum of 30 days of lens wear during the last 5 years).
  • The subject's vertexed best sphere distance refraction must be between -0.75 and -5.00 D in both eyes.
  • Cylinder refraction less than or equal to -0.75 D in both eyes (any axis).
  • The subject must have corrected visual acuity of 20/20 or better 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, which may interfere with contact lens wear.
  • Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye.
  • Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
  • Current wearers of rigid or hybrid contact lenses.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  • History of binocular vision abnormality or strabismus.
  • Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician).
  • Clinically significant (grade 3 or 4) corneal edema, pterygium, corneal vascularization, corneal staining, or any other abnormalities of the cornea or conjunctiva which may interfere with the study measurements.
  • Strabismus, suppression or amblyopia.
  • Any ocular infection.

Treatment and study plan

Senofilcon A

Device

A soft spherical contact lens

lotrafilcon B

Device

Primary outcomes

  1. Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking

    Time frame: 2 hours post insertion

    Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.

  2. Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink

    Time frame: 2 hours post insertion

    Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.

  3. Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink

    Time frame: 2 hours post insertion

    Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 28, 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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