Skip to main content
OpenTrials
Completed

NCT Number: NCT02484586

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brien Holden Vision Institute

Sydney, New South Wales, 2052, Australia

About this study

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.

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.
  • 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.

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, 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.

Treatment and study plan

etafilcon A

Device

Prototype lens material

Nelfilcon A

Device

Control lens for presbyope group

Other names: Dailies Aqua Comfort Plus Multifocal

Nesofilcon A

Device

Control lens for presbyope group

Other names: Biotrue ONEday for Presbyopia

somofilcon A

Device

Control lens for presbyope group

Other names: Clariti 1 Day Multifocal

58% Poly-HEMA

Device

Control lens for presbyope group

Other names: SEED 1dayPure moisture Multistage

omafilcon A

Device

Control lens for non-presbyope group

Other names: Proclear Multifocal

Primary outcomes

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

    Time frame: Approximately 1 week after lens fitting

    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.

Secondary outcomes

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

    Time frame: Approximately 1 week after lens fitting

    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.

Sponsors and collaborators

Lead sponsor

Brien Holden Vision

Industry

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2015
Registry last updated
Sep 11, 2017

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.

Published trials that share one or more normalized conditions with this study.