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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: balafilcon A (8.6)
* Device: balafilcon A (8.3)
* Device: senofilcon A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contralateral lens comfort comparisons<br>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)<br>* To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.<br>* Other names: Bausch & Lomb PureVision 8.6;Device: balafilcon A (8.3)<br>* To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.<br>* Other names: Bausch & Lomb PureVision 8.3;Device: senofilcon A<br>* To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.<br>* Other names: Johnson & Johnson Acuvue Oasys;|

What is the study measuring?
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Primary Outcome Measures

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