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

Not Applicable

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: balafilcon A (8.6); Device: balafilcon A (8.3); Device: senofilcon A

• Registration Number: NCT01840787
• Lead Sponsor: University of Waterloo

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.

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-19
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-26
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contralateral lens comfort comparisons	balafilcon A (8.6)	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.
Contralateral lens comfort comparisons	balafilcon A (8.3)	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.
Contralateral lens comfort comparisons	senofilcon A	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science; 🇨🇦 Waterloo, Ontario, Canada