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Dispensing Study to Assess Visual Performance of Prototype Contact Lenses

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ClinicalTrials.gov Identifier: NCT02214797
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Brien Holden Vision

Brief 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.

Condition or disease Intervention/treatment Phase
Presbyopia Refractive Error Device: Etafilcon A, Lotrafilcon B , Senofilcon A Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dispensing Study to Assess Visual Performance of Prototype Contact Lenses
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Presbyopic group - Low Add

40 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.

Device: Etafilcon A, Lotrafilcon B , Senofilcon A
Other Names:
  • Control lenses
  • Non-presbyopic group
  • Brand name: Air Optix® Aqua , Acuvue® 1-Day Moist
  • Lens material: Lotrafilcon B , Etafilcon A
  • Presbyopic group
  • Brand name: Air Optix® Multifocal, Acuvue® Oasys for Presbyopia
  • Lens material Lotrafilcon B, Senofilcon A
  • Test lens
  • Brand name: Iteration X
  • Lens material: Etafilcon A

Presbyopic group - Med Add

40 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.

Device: Etafilcon A, Lotrafilcon B , Senofilcon A
Other Names:
  • Control lenses
  • Non-presbyopic group
  • Brand name: Air Optix® Aqua , Acuvue® 1-Day Moist
  • Lens material: Lotrafilcon B , Etafilcon A
  • Presbyopic group
  • Brand name: Air Optix® Multifocal, Acuvue® Oasys for Presbyopia
  • Lens material Lotrafilcon B, Senofilcon A
  • Test lens
  • Brand name: Iteration X
  • Lens material: Etafilcon A

Presbyopic group - High Add

40 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.

Device: Etafilcon A, Lotrafilcon B , Senofilcon A
Other Names:
  • Control lenses
  • Non-presbyopic group
  • Brand name: Air Optix® Aqua , Acuvue® 1-Day Moist
  • Lens material: Lotrafilcon B , Etafilcon A
  • Presbyopic group
  • Brand name: Air Optix® Multifocal, Acuvue® Oasys for Presbyopia
  • Lens material Lotrafilcon B, Senofilcon A
  • Test lens
  • Brand name: Iteration X
  • Lens material: Etafilcon A

Non-presbyopic group

18 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.

Device: Etafilcon A, Lotrafilcon B , Senofilcon A
Other Names:
  • Control lenses
  • Non-presbyopic group
  • Brand name: Air Optix® Aqua , Acuvue® 1-Day Moist
  • Lens material: Lotrafilcon B , Etafilcon A
  • Presbyopic group
  • Brand name: Air Optix® Multifocal, Acuvue® Oasys for Presbyopia
  • Lens material Lotrafilcon B, Senofilcon A
  • Test lens
  • Brand name: Iteration X
  • Lens material: Etafilcon A




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Change in subjective response over 1-week of lens wear [ Time Frame: After about 40 mins of lens wear and after 2 days, 4 days and 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.



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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
  • 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)

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 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
  • 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


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): NCT02214797


Locations
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Australia, New South Wales
Brien Holden Vision Institue, Clinical Research Trials Center
Sydney, New South Wales, Australia, 2052
Sponsors and Collaborators
Brien Holden Vision
Investigators
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Principal Investigator: Jiyoon Chung, BOptom Brien Holden Vision Institute

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brien Holden Vision
ClinicalTrials.gov Identifier: NCT02214797     History of Changes
Other Study ID Numbers: CRTC2013-02
ACTRN12614000011684 ( Registry Identifier: ANZCTR )
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015
Keywords provided by Brien Holden Vision:
Presbyopia
Refractive Error
Contact Lenses
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases