Visual Performance of Prototype Contact Lens Designs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-11-30

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

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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.

Conditions

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Presbyopia Refractive Error

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Non-presbyopic group

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.

Group Type OTHER

Etafilcon A, Senofilcon A

Intervention Type DEVICE

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).

Presbyopic group

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.

Group Type OTHER

Etafilcon A, Senofilcon A

Intervention Type DEVICE

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).

Interventions

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Etafilcon A, Senofilcon A

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).

Intervention Type DEVICE

Other Intervention Names

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Control lenses Non-presbyopic group Brand name: 1-Day Acuvue® Moist® Lens material: Etafilcon A Presbyopic group Brand name: Acuvue® Oasys® for Presbyopia Lens material: Senofilcon A Test lens Brand name: Iteration X

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.

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes