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

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
University of Waterloo
ClinicalTrials.gov Identifier:
NCT01840787
First received: April 19, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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 Intervention
Dry Eye Syndromes
Device: balafilcon A (8.6)
Device: balafilcon A (8.3)
Device: senofilcon A

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: A Pilot Study on the Use of a Sensory Panel to Assess Comfort Between Three Different Contact Lenses

Resource links provided by NLM:


Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • Change in eye comfort ratings [ Time Frame: Prior to, and after lens insertion in the morning, and then again 8 hours later. ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: April 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840787

Locations
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
Principal Investigator: Trefford Simpson, DipOptom University of Waterloo School of Optometry & Vision Science
  More Information

No publications provided

Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT01840787     History of Changes
Other Study ID Numbers: P/433/12/IIS-L
Study First Received: April 19, 2013
Last Updated: July 9, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on October 19, 2014