Dispensing Study to Assess Visual Performance of Prototype Contact Lenses

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

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-06-30

Brief Summary

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The aim of this study is to assess visual performance of prototype soft contact lens designs compared to commercially available contact lenses over one-week of lens wear.

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Detailed Description

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Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where participants will wear prototype (test) and commercial (control) lenses bilaterally. Participants will be stratified based on their refractive error into either presbyopic or non-presbyopic group. Each of the stratified group will have a maximum of 4 parallel arms. Up to 4 test lens designs will be assessed against the control/s in each parallel arm in a randomized cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Conditions

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Presbyopia Refractive Error

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Presbyopic group - Low Add

40 years and over Add of less than +1.50D

Control lens : Lotrafilcon B and Senofilcon A

Test lens: Etafilcon A

Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion. Each lenses will be worn for a week with a minimum 2 day washout period between the lens types. Each lens will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Group Type OTHER

Etafilcon A, Lotrafilcon B , Senofilcon A

Intervention Type DEVICE

Presbyopic group - Med Add

40 years and over Add of +1.50D to +1.75D

Control lens : Lotrafilcon B and Senofilcon A

Test lens: Etafilcon A

Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Group Type OTHER

Etafilcon A, Lotrafilcon B , Senofilcon A

Intervention Type DEVICE

Presbyopic group - High Add

40 years and over Add of +2.00D to +2.50D

Control lens : Lotrafilcon B and Senofilcon A

Test lens: Etafilcon A

Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Group Type OTHER

Etafilcon A, Lotrafilcon B , Senofilcon A

Intervention Type DEVICE

Non-presbyopic group

18 to 39 years old No Add

Control lens : Lotrafilcon B and Etafilcon A

Test lens: Etafilcon A

Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Group Type OTHER

Etafilcon A, Lotrafilcon B , Senofilcon A

Intervention Type DEVICE

Interventions

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Etafilcon A, Lotrafilcon B , Senofilcon A

Intervention Type DEVICE

Other Intervention Names

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Control lenses Non-presbyopic group Brand name: Air Optix® Aqua , Acuvue® 1-Day Moist Lens material: Lotrafilcon B , Etafilcon A Presbyopic group Brand name: Air Optix® Multifocal, Acuvue® Oasys for Presbyopia Lens material Lotrafilcon B, Senofilcon A Test lens Brand name: Iteration X Lens material: Etafilcon A

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 18 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 in each eye with contact lenses
* Be willing to not wear contact lenses for a minimum of 2 days before each stage of the clinical trial (after informed consent)

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 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
* Eye surgery within 12 weeks immediately prior to enrolment for this trial.
* Previous corneal refractive surgery
* Contraindications to contact lens wear
* Known allergy or intolerance to ingredients in any of the clinical trial products

The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes