Visual Performance of Prototype Contact Lens Designs

November 4, 2014 updated by: Brien Holden Vision
The aim of this study is to assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, participant-masked, randomised, stratified, crossover, bilateral wear, dispensing clinical trial where participants will wear the prototype (test) and the commercial (control) lens. A minimum of an overnight washout period is required between the fitting /assessment visits.

Study Type

Interventional

Enrollment (Actual)

91

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, Clinical Research Trials Center

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

5 years and older (Child, 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 7 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 with both eyes 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, 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.
  • Eye surgery within 12 weeks immediately prior to enrolment for this 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.

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Non-presbyopic group

Non-presbyopic group: age ranging from 7 to 39 years

At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue 1- Day Moist, etafilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit.

For each fitting visit, lenses will be fitted bilaterally.
Device: Etafilcon A, Senofilcon A
1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).
Other Names:
  • Test lens
  • Control lenses
  • Non-presbyopic group
  • Brand name: 1-Day Acuvue® Moist®
  • Lens material: Etafilcon A
  • Presbyopic group
  • Brand name: Acuvue® Oasys® for Presbyopia
  • Lens material: Senofilcon A
  • Brand name: Iteration X
Other: Presbyopic group

Presbyopic group: age 40 and above

At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue Oasys for Presbyopia, senofilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit.

For each fitting visit, lenses will be fitted bilaterally.
Device: Etafilcon A, Senofilcon A
1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).
Other Names:
  • Test lens
  • Control lenses
  • Non-presbyopic group
  • Brand name: 1-Day Acuvue® Moist®
  • Lens material: Etafilcon A
  • Presbyopic group
  • Brand name: Acuvue® Oasys® for Presbyopia
  • Lens material: Senofilcon A
  • Brand name: Iteration X

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual performance
Time Frame: After about 20 minutes of lens wear
Visual acuity
After about 20 minutes of lens wear

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective responses
Time Frame: After about 40 minutes of lens wear
Subjective ratings of vision
After about 40 minutes of lens wear

Collaborators and Investigators

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

Sponsor

Brien Holden Vision

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

July 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRTC2014-02

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.

Clinical Trials on Refractive Error

Clinical Trials on Etafilcon A, Senofilcon A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe