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Completed

NCT Number: NCT01840787

A Pilot Study on the Use of a Sensory Panel to Assess Comfort Between Three Different Contact Lenses

As new contact lens products continue to be developed and improved, it's becoming harder for some individuals to tell whether one product is different from another. In addition, not everyone has the same level of sensitivity of their eyes, making it difficult for these judgments to be made. The purpose of this study is to explore the idea of using a pre-determined "expert panel" of individuals who are able to tell differences between contact lenses based on their comfort.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science

Waterloo, Ontario, N2L 3G1, Canada

About this study

As technology continues to advance, contact lenses and lens care products are becoming harder to differentiate. In addition, assessing comfort in clinical trials is complicated, with full-masking behind hard to achieve and the psychology of the participant having unknown impact on the results. While the development of a reliable system to assess comfort would be beneficial for the research and development of new products, the use of a "sensory panel" itself may also lead to a better understanding of the drivers of discomfort at the end of the day.

The objective of the study is to explore the use of a sensory panel, defined as individuals who have a good correlation between subjective and objective measures of discomfort, at rating the comfort of various contact lenses.

The hypothesis is that in the "discriminative" group, the matrix of paired comparisons (between lens dissimilarity) is related to the ranked comfort of the lenses, while for the "poorly discriminative" group, the matrix of the dissimilarities will be random. An additional hypothesis is that the "discriminative" group will be less random than the entire group.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is an adapted soft contact lens wearer;
  • Has a contact lens prescription between +4.00 to -6.00D;
  • Has astigmatism <= 1.00D;
  • Has vision of 20/40 or better in both eyes when wearing contact lenses

Exclusion criteria

  • Is participating in any concurrent clinical or research study;
  • Has any known active ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment, determined verbally;
  • Is aphakic;
  • Has undergone refractive surgery;
  • Is an employee of the Centre for Contact Lens Research;
  • Has anisometropia of >=1.00D
  • Has a difference in comfort of 20 (on a 0-100 scale) between eyes when not wearing contact lenses.

Treatment and study plan

balafilcon A (8.6)

Device

To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.

Other names: Bausch & Lomb PureVision 8.6

balafilcon A (8.3)

Device

To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.

Other names: Bausch & Lomb PureVision 8.3

Senofilcon A

Device

To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.

Other names: Johnson & Johnson Acuvue Oasys

Primary outcomes

  1. Change in eye comfort ratings

    Time frame: Prior to, and after lens insertion in the morning, and then again 8 hours later.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Alcon Research

Registry information

Acronym: NAISMITH

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 26, 2013
Registry last updated
Dec 16, 2015

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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