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

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ClinicalTrials.gov Identifier: NCT01840787
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : December 16, 2015
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
University of Waterloo

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: balafilcon A (8.6) Device: balafilcon A (8.3) Device: senofilcon A Not Applicable

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: A Pilot Study on the Use of a Sensory Panel to Assess Comfort Between Three Different Contact Lenses
Study Start Date : April 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arms and Interventions
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Arm Intervention/treatment
Experimental: Contralateral lens comfort comparisons
Subjects will be randomized into receiving balafilcon A (8.3), or balafilcon A (8.6), or senofilcon A in one eye, and balafilcon A (8.3), or balafilcon A (8.6), or senofilcon A in the other eye.
 Device: balafilcon A (8.6)
To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
Other Name: Bausch & Lomb PureVision 8.6

Device: balafilcon A (8.3)
To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
Other Name: Bausch & Lomb PureVision 8.3

Device: senofilcon A
To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
Other Name: Johnson & Johnson Acuvue Oasys


Outcome Measures
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Primary Outcome Measures :
  1. Change in eye comfort ratings [ Time Frame: Prior to, and after lens insertion in the morning, and then again 8 hours later. ]

Eligibility Criteria
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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840787


Locations
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Canada, Ontario
Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
University of Waterloo
Alcon Research
Investigators
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Principal Investigator: Trefford Simpson, DipOptom University of Waterloo School of Optometry & Vision Science
More Information
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Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT01840787     History of Changes
Other Study ID Numbers: 18801
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases