Dry Eye Syndromes
Conditions
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.
Interventions
DEVICEbalafilcon A (8.6)
To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
DEVICEbalafilcon A (8.3)
To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
DEVICEsenofilcon A
To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
Sponsors
Alcon Research
University of Waterloo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in eye comfort ratings | Prior to, and after lens insertion in the morning, and then again 8 hours later. |
Countries
Canada
Outcome results
None listed