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

September 8, 2017 updated by: Brien Holden Vision
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2052
        • Brien Holden Vision Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Presbyope group

40 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.
Device: Etafilcon A
Prototype lens material
Device: Etafilcon A
Control lens for presbyope group
Other Names:
  • 1-Day Acuvue Moist Multifocal
Device: Nelfilcon A
Control lens for presbyope group
Other Names:
  • Dailies Aqua Comfort Plus Multifocal
Device: Nesofilcon A
Control lens for presbyope group
Other Names:
  • Biotrue ONEday for Presbyopia
Device: Nelfilcon A
Control lens for non-presbyope group
Other Names:
  • Dailies Aqua Comfort Plus
Device: Etafilcon A
Control lens for non-presbyope group
Other Names:
  • 1-Day Acuvue Moist
Device: Somofilcon A
Control lens for presbyope group
Other Names:
  • Clariti 1 Day Multifocal
Device: 58% Poly-HEMA
Control lens for presbyope group
Other Names:
  • SEED 1dayPure moisture Multistage
Other: Non-Presbyope group

18-39 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.
Device: Etafilcon A
Prototype lens material
Device: Etafilcon A
Control lens for presbyope group
Other Names:
  • 1-Day Acuvue Moist Multifocal
Device: Nelfilcon A
Control lens for presbyope group
Other Names:
  • Dailies Aqua Comfort Plus Multifocal
Device: Nelfilcon A
Control lens for non-presbyope group
Other Names:
  • Dailies Aqua Comfort Plus
Device: Etafilcon A
Control lens for non-presbyope group
Other Names:
  • 1-Day Acuvue Moist
Device: Omafilcon A
Control lens for non-presbyope group
Other Names:
  • Proclear Multifocal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 1 week after lens fitting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 1 week after lens fitting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brien Holden Vision

Investigators

  • Principal Investigator: Jennifer Sha, BOptom/BSc, Brien Holden Vision Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

February 7, 2017

Study Completion (Actual)

February 7, 2017

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRTC2014-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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