Visual Performance of Prototype Contact Lens Designs

Study Overview
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Brief Summary
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The aim of this study is to assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens

Detailed Description
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Prospective, participant-masked, randomised, stratified, crossover, bilateral wear, dispensing clinical trial where participants will wear the prototype (test) and the commercial (control) lens. A minimum of an overnight washout period is required between the fitting /assessment visits.

Official Title
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Visual Performance of Prototype Contact Lens Designs

Conditions
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Presbyopia, Refractive Error

Intervention / Treatment
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* Device: Etafilcon A, Senofilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. Be at least 7 years old, male or female. Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator. Have ocular health findings considered to be normal and which would not prevent the participant from safely wearing contact lenses. Correctable to at least 6/12 (20/40) or better with both eyes with contact lenses. Be suitable and willing to wear contact lenses. Exclusion Criteria: Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses. Any systemic disease that adversely affects ocular health e.g. diabetes, Graves' disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial. Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial. Eye surgery within 12 weeks immediately prior to enrolment for this trial. NB: Systemic antihistamines are allowed on an as needed basis, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.

Ages Eligible for Study
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Minimum Age: 7 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Non-presbyopic group<br>Non-presbyopic group: age ranging from 7 to 39 years At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue 1- Day Moist, etafilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit. For each fitting visit, lenses will be fitted bilaterally. | Device: Etafilcon A, Senofilcon A<br>* 1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).<br>* Other names: Brand name: Iteration X;|
| Other: Presbyopic group<br>Presbyopic group: age 40 and above At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue Oasys for Presbyopia, senofilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit. For each fitting visit, lenses will be fitted bilaterally. | Device: Etafilcon A, Senofilcon A<br>* 1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).<br>* Other names: Brand name: Iteration X;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual performance | Visual acuity | After about 20 minutes of lens wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective responses | Subjective ratings of vision | After about 40 minutes of lens wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Presbyopia, Refractive error correction, Contact lenses