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OpenTrials
Completed

NCT Number: NCT02214797

Dispensing Study to Assess Visual Performance of Prototype Contact Lenses

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brien Holden Vision Institue, Clinical Research Trials Center

Sydney, New South Wales, 2052, Australia

About this study

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.

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 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

Treatment and study plan

Etafilcon A, Lotrafilcon B , Senofilcon A

Device

Other names: 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

Primary outcomes

  1. Change in visual performance over 1-week lens wear

    Time frame: after about 20 minutes of lens wear and after about 1 week of lens wear

    Visual Acuity Visual acuity will be recorded on an interval scale. Data will be summarised as means ± standard deviations. No transformation is likely to be required. Visual acuity will be compared between test and control lens types and time across 1 week. Interactions will be tested and, if present, the significance of lens types will be determined at each time point and over time for each lens type. Visual acuity will be analysed using linear mixed model with subject random intercepts and / or paired t-test.

Secondary outcomes

  1. Change in subjective response over 1-week of lens wear

    Time frame: After about 40 mins of lens wear and after 2 days, 4 days and 1 week of lens wear

    Subjective ratings Questionnaire Subjective ratings will be recorded on a scale of 1 to 10 on steps of 1. Data will be summarised as means ± standard deviations. No transformation is likely to be required. Subjective ratings will be compared between test and control lens types and time across 1 week. Interactions will be tested and, if present, the significance of lens type will be determined at each time point and over time for each lens type. Subjective ratings will be analysed using linear mixed model with subject random intercepts and / or paired t-test.

Sponsors and collaborators

Lead sponsor

Brien Holden Vision

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 12, 2014
Registry last updated
Jun 25, 2015

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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