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

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ClinicalTrials.gov Identifier: NCT02484586
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Brien Holden Vision

Brief 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.

Condition or disease Intervention/treatment Phase
Presbyopia Refractive Error Device: Etafilcon A Device: Nelfilcon A Device: Nesofilcon A Device: Somofilcon A Device: 58% Poly-HEMA Device: Omafilcon A Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
Study Start Date : October 2015
Actual Primary Completion Date : February 7, 2017
Actual Study Completion Date : February 7, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 1-Day Acuvue Moist Multifocal

Device: Nelfilcon A
Control lens for presbyope group
Other Name: Dailies Aqua Comfort Plus Multifocal

Device: Nesofilcon A
Control lens for presbyope group
Other Name: Biotrue ONEday for Presbyopia

Device: Somofilcon A
Control lens for presbyope group
Other Name: Clariti 1 Day Multifocal

Device: 58% Poly-HEMA
Control lens for presbyope group
Other Name: SEED 1dayPure moisture Multistage

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: Nelfilcon A
Control lens for non-presbyope group
Other Name: Dailies Aqua Comfort Plus

Device: Etafilcon A
Control lens for non-presbyope group
Other Name: 1-Day Acuvue Moist

Device: Omafilcon A
Control lens for non-presbyope group
Other Name: Proclear Multifocal




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484586


Locations
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Australia, New South Wales
Brien Holden Vision Institute
Sydney, New South Wales, Australia, 2052
Sponsors and Collaborators
Brien Holden Vision
Investigators
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Principal Investigator: Jennifer Sha, BOptom/BSc Brien Holden Vision Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brien Holden Vision
ClinicalTrials.gov Identifier: NCT02484586     History of Changes
Other Study ID Numbers: CRTC2014-04
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Keywords provided by Brien Holden Vision:
Presbyopia
Refractive error
Contact lens
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases