NAISMITHA Pilot Study on the Use of a Sensory Panel to Assess Comfort Between Three Different Contact Lenses
balafilcon A (8.6)
+ balafilcon A (8.3)
+ senofilcon A
Eye Diseases
+ Lacrimal Apparatus Diseases
+ Dry Eye Syndromes
Summary
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.63 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science
Waterloo, CanadaOpen Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science in Google Maps