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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: balafilcon A (8.6); Device: balafilcon A (8.3); Device: senofilcon A

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Johnson & Johnson Acuvue Oasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in eye comfort ratings	Prior to, and after lens insertion in the morning, and then again 8 hours later.

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Trefford Simpson, DipOptom, University of Waterloo School of Optometry & Vision Science

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: April 19, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 18801 (University of California, San Francisco)