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Completed

NCT Number: NCT01473160

Daily Disposable Contact Lens Tear Film Study

The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aston University

Birmingham, B4 7ET, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be of legal age of consent and sign Informed Consent document.
  • Willing and able to wear spherical contact lenses for 16 hours.
  • Willing and able to wear spherical contact lenses within the available range of powers.
  • Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Anterior segment infection, inflammation, or abnormality.
  • Any use of systemic medications for which contact lens wear could be contraindicated.
  • History of refractive surgery or irregular cornea.
  • Currently enrolled in any clinical trial.
  • Eye injury within twelve weeks prior to enrollment.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

delefilcon A contact lens

Device

CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear

Other names: DAILIES TOTAL1

Narafilcon A contact lens

Device

Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.

Other names: 1-DAY ACUVUE TruEye

Primary outcomes

  1. Number of Participants With Corrected Visual Acuity of 0.0 or Better

    Time frame: Up to 16 hours after lens insertion

    Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.

  2. Pre-Lens Noninvasive Tear Break-Up Time

    Time frame: Up to 16 hours after lens insertion

    The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.

  3. Average Tear Meniscus Height

    Time frame: Up to 16 hours after lens insertion

    The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.

  4. Average Ocular Surface Temperature

    Time frame: Up to 16 hours after lens insertion

    Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.

Secondary outcomes

  1. Subjective Comfort

    Time frame: Up to 16 hours after lens insertion

    Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, "How comfortable is the lens feeling at present?"

  2. Subjective Vision

    Time frame: Up to 16 hours after lens insertion

    Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, "What is the quality of your vision with the lens at present?"

  3. Number of Participants With Adequate Lens Fit

    Time frame: Up to 16 hours after lens insertion

    Lens fit was assessed by the investigator with a biomicroscope (slit lamp).

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Collaborators

  • Aston University

Registry information

Official study title

DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 17, 2011
Registry last updated
Apr 17, 2013

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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