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OpenTrials
Completed

NCT Number: NCT01839318

Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses

The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.

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Key information

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign Informed Consent.
  • Adapted soft contact lens wearer.
  • Willing to wear contact lenses up to 12 hours and attend all study visits.
  • Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
  • Contact lens prescription within the power range specified in the protocol.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
  • Any use of systemic or ocular medications that would contraindicate contact lens wear.
  • Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens.
  • History of herpetic keratitis, ocular surgery, or irregular cornea.
  • Known pregnancy.
  • Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses.
  • Participation in any clinical study within 30 days of Visit 1.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Nelfilcon A contact lenses

Device

Other names: DAILIES® AquaComfort Plus®

Omafilcon A contact lenses

Device

Other names: Proclear® 1 day

Etafilcon A contact lenses

Device

Other names: 1-DAY ACUVUE® MOIST®

Primary outcomes

  1. Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours

    Time frame: Hour 8

    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 contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.

Secondary outcomes

  1. Total Wettability Score

    Time frame: Hour 8

    The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 24, 2013
Registry last updated
Jun 20, 2014

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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