Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

balafilcon A (8.6)

+ balafilcon A (8.3)

+ senofilcon A

Device
Who is being recruted

Eye Diseases

+ Lacrimal Apparatus Diseases

+ Dry Eye Syndromes

Over 17 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity of Waterloo
Last updated: December 16, 2015
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorUniversity of Waterloo
Last updated: December 16, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

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.
Conditions
Criteria

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

Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes

Criteria

7 inclusion criteria required to participate
Has a contact lens prescription between +4.00 to -6.00D

Has astigmatism <= 1.00D

Has read and signed an information consent letter

Has vision of 20/40 or better in both eyes when wearing contact lenses

Show More Criteria

11 exclusion criteria prevent from participating
Has a difference in comfort of 20 (on a 0-100 scale) between eyes when not wearing contact lenses

Has a systemic condition that in the opinion of the investigator may affect a study outcome variable

Has anisometropia of >= 1.00D

Has any known active ocular disease and/or infection

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study 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 &amp; Vision Science

Waterloo, CanadaOpen Centre for Contact Lens Research, University of Waterloo School of Optometry &amp; Vision Science in Google Maps
CompletedOne Study Center