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PresbyopiaNCT02214797

Dispensing Study to Assess Visual Performance of Prototype Contact Lenses

A study testing Etafilcon A, Lotrafilcon B , Senofilcon 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 visual performance of prototype soft contact lens designs compared to commercially available contact lenses over one-week of lens wear. 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, Lotrafilcon B , Senofilcon A
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteAustralia
Study dates
Sep 2014to Jun 2015
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
  • 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)

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, 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Brien Holden Vision Institue, Clinical Research Trials Center

    Sydney, New South Wales, 2052

Other trials in Australia

About this study

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.

Read the detailed description

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.

Being tested
Etafilcon A, Lotrafilcon B , Senofilcon A
Keywords
Presbyopia, Refractive Error, Contact Lenses
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 A, Lotrafilcon B , Senofilcon ADevice

    Also called Control lenses, Non-presbyopic group, Brand name: Air Optix® Aqua , Acuvue® 1-Day Moist, Lens material: Lotrafilcon B , Etafilcon A

Study groups in NCT02214797
Study groupRoleWhat they receive
Presbyopic group - Low AddOther40 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.
Receives: Device: Etafilcon A, Lotrafilcon B , Senofilcon A
Presbyopic group - Med AddOther40 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.
Receives: Device: Etafilcon A, Lotrafilcon B , Senofilcon A
Presbyopic group - High AddOther40 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.
Receives: Device: Etafilcon A, Lotrafilcon B , Senofilcon A
Non-presbyopic groupOther18 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.
Receives: Device: Etafilcon A, Lotrafilcon B , Senofilcon A

What is being measured

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

  1. Change in visual performance over 1-week 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.

    Measured: after about 20 minutes of lens wear and after about 1 week of lens wear

Secondary outcomes (1)

  1. Change in subjective response over 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.

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

Timeline

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

  1. First posted12 Aug 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

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
Single blind
Who is masked
Participant
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02214797
Sponsor's protocol ID
CRTC2013-02
Other IDs
ACTRN12614000011684
Status last verified
Jun 2015
First submitted
7 Aug 2014
Last updated
25 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Young G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens wearers. Ophthalmic Physiol Opt. 2002 Nov;22(6):516-27. doi: 10.1046/j.1475-1313.2002.00066.x.

    PubMed 12477016

  • Stapleton F, Keay L, Edwards K, Naduvilath T, Dart JK, Brian G, Holden BA. The incidence of contact lens-related microbial keratitis in Australia. Ophthalmology. 2008 Oct;115(10):1655-62. doi: 10.1016/j.ophtha.2008.04.002. Epub 2008 Jun 5.

    PubMed 18538404

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Etafilcon A, Lotrafilcon B , Senofilcon 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 9 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 25 Jun 2015. 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?

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). 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 NCT02214797, which also lists 3 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 25 Jun 2015.

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