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PresbyopiaNCT02484586

Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses

A study testing Etafilcon A, Nelfilcon A and Nesofilcon A in people with Presbyopia and Refractive Error, run by Brien Holden Vision at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to assess the visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Presbyopia, Refractive Error
What is being tested?
Etafilcon A, Nelfilcon A and Nesofilcon A
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
1 siteAustralia
Study dates
Oct 2015to 7 Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
  • Be suitable and willing to wear contact lenses.

Who cannot join

  • 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, Sjogrens 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. Ocular medication can be prescribed during the course of the trial as per standard optometric practice.
  • 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. Note: 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Brien Holden Vision Institute

    Sydney, New South Wales, 2052

Other trials in Australia

About this study

The aim of this study is to assess the visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses.

Read the detailed description

Prospective, double-masked, crossover, bilateral wear, dispensing clinical trial where participants will wear multiple prototype (test) and commercial (control) lenses.

Multiple prototype contact lens designs will be assessed against commercial control lenses during the study, where each design will be worn for up to a week. There will be a minimum 1 night washout period between lens designs.

Being tested
Etafilcon A, Nelfilcon A, Nesofilcon A, Somofilcon A, 58% Poly-HEMA
Keywords
Presbyopia, Refractive error, Contact lens
Medical subject headings
Presbyopia, Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Etafilcon ADevice

    Prototype lens material

  • Etafilcon ADevice

    Also called 1-Day Acuvue Moist Multifocal

    Control lens for presbyope group

  • Nelfilcon ADevice

    Also called Dailies Aqua Comfort Plus Multifocal

    Control lens for presbyope group

  • Nesofilcon ADevice

    Also called Biotrue ONEday for Presbyopia

    Control lens for presbyope group

  • Nelfilcon ADevice

    Also called Dailies Aqua Comfort Plus

    Control lens for non-presbyope group

  • Etafilcon ADevice

    Also called 1-Day Acuvue Moist

    Control lens for non-presbyope group

  • Somofilcon ADevice

    Also called Clariti 1 Day Multifocal

    Control lens for presbyope group

  • 58% Poly-HEMADevice

    Also called SEED 1dayPure moisture Multistage

    Control lens for presbyope group

  • Omafilcon ADevice

    Also called Proclear Multifocal

    Control lens for non-presbyope group

Study groups in NCT02484586
Study groupRoleWhat they receive
Presbyope groupOther40 years and over with a reading add. Control lens: Etafilcon A, Nelfilcon A, Nesofilcon A, Somofilcon A, 58% Poly-HEMA Test lens: Etafilcon A Up to 10 prototype contact lens designs and at least 1 commercially available contact lens designs will be worn by each participant for up to a week on a daily disposable modality. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit as late as Day 7, but may be as early as 6 hours after the Fitting Visit). There will be a minimum 1 night washout period between lens designs, i.e. after an assessment visit but before the next fitting visit.
Receives: Device: Etafilcon A; Device: Nelfilcon A; Device: Nesofilcon A; Device: Somofilcon A; Device: 58% Poly-HEMA
Non-Presbyope groupOther18-39 years with no reading add. Control lens: Etafilcon A, Nelfilcon A, Omafilcon A Test lens: Etafilcon A Up to 10 prototype contact lens designs and at least 1 commercially available contact lens designs will be worn by participants for up to a week on a daily disposable modality. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit as late as Day 7, but may be as early as 6 hours after the Fitting Visit). There will be a minimum 1 night washout period between lens designs, i.e. after an assessment visit but before the next fitting visit.
Receives: Device: Etafilcon A; Device: Nelfilcon A; Device: Omafilcon A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale

    For each lens, visual acuity will be measured at distance with a computerised LogMAR chart and at near with a near LogMAR chart. Data will be summarised as means +/- standard deviations. No transformation is likely to be required. Visual acuity will be compared between each lens design and control lens types. The significance of lens design will be determined for each visit.

    Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of visual acuity. Analysis will be performed within each study arm namely presbyopes and non-presbyopes.

    Measured: Approximately 1 week after lens fitting

Secondary outcomes (1)

  1. Subjective rating of vision on a 1-10 visual analogue scale

    For each lens, subjective ratings of vision will be assessed with a questionnaire based on a 1 to 10 scale in steps of 1. The questionnaire has been designed specifically for this study. Data will be summarised as means +/- standard deviations. No transformation is likely to be required. Subjective ratings will be compared between each lens design and control lens types. The significance of lens design will be determined for each visit. Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of subjective ratings. Analysis will be performed within each study arm namely presbyopes and non-presbyopes.

    Measured: Approximately 1 week after lens fitting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion7 Feb 2017
  4. Study completion7 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02484586
Sponsor's protocol ID
CRTC2014-04
Status last verified
Sep 2017
First submitted
24 Jun 2015
Last updated
11 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • Jong M, Tilia D, Sha J, Diec J, Thomas V, Bakaraju RC. The Relationship between Visual Acuity, Subjective Vision, and Willingness to Purchase Simultaneous-image Contact Lenses. Optom Vis Sci. 2019 Apr;96(4):283-290. doi: 10.1097/OPX.0000000000001359.

    PubMed 30907859

  • Sha J, Tilia D, Kho D, Amrizal H, Diec J, Yeotikar N, Jong M, Thomas V, Bakaraju RC. Visual Performance of Daily-disposable Multifocal Soft Contact Lenses: A Randomized, Double-blind Clinical Trial. Optom Vis Sci. 2018 Dec;95(12):1096-1104. doi: 10.1097/OPX.0000000000001311.

    PubMed 30451806

Questions about this trial

What is this clinical trial studying?

A study testing Etafilcon A, Nelfilcon A and Nesofilcon A in people with Presbyopia and Refractive Error, run by Brien Holden Vision at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale (time frame: Approximately 1 week after lens fitting). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02484586, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.

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Clinical Trial NCT02484586 | AzTrials