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OpenTrials
Completed

NCT Number: NCT02193555

Visual Performance of Prototype Contact Lens Designs

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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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brien Holden Vision Institute, Clinical Research Trials Center

Sydney, New South Wales, 2052, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etafilcon A, Senofilcon A

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).

Other names: 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

Primary outcomes

  1. Visual performance

    Time frame: After about 20 minutes of lens wear

    Visual acuity

Secondary outcomes

  1. Subjective responses

    Time frame: After about 40 minutes of lens wear

    Subjective ratings of vision

Sponsors and collaborators

Lead sponsor

Brien Holden Vision

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2014
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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