Back to resultsDispensing Study to Assess Visual Performance of Prototype Contact Lenses
Primary Purpose
Presbyopia, Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Etafilcon A, Lotrafilcon B , Senofilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, Refractive Error, Contact Lenses
Eligibility 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
Sites / Locations
- Brien Holden Vision Institue, Clinical Research Trials Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Presbyopic group - Low Add
Presbyopic group - Med Add
Presbyopic group - High Add
Non-presbyopic group
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Change in visual performance over 1-week 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
Change in subjective response over 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02214797
Brief Title
Dispensing Study to Assess Visual Performance of Prototype Contact Lenses
Official Title
Dispensing Study to Assess Visual Performance of Prototype Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brien Holden Vision
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Refractive Error
Keywords
Presbyopia, Refractive Error, Contact Lenses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Presbyopic group - Low Add
Arm Type
Other
Arm Description
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.
Arm Title
Presbyopic group - Med Add
Arm Type
Other
Arm Description
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.
Arm Title
Presbyopic group - High Add
Arm Type
Other
Arm Description
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.
Arm Title
Non-presbyopic group
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Etafilcon A, Lotrafilcon B , Senofilcon A
Other Intervention Name(s)
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 Measure Information:
Title
Change in visual performance over 1-week lens wear
Description
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.
Time Frame
after about 20 minutes of lens wear and after about 1 week of lens wear
Secondary Outcome Measure Information:
Title
Change in subjective response over 1-week of lens wear
Description
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.
Time Frame
After about 40 mins of lens wear and after 2 days, 4 days and 1 week of lens wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiyoon Chung, BOptom
Organizational Affiliation
Brien Holden Vision Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brien Holden Vision Institue, Clinical Research Trials Center
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2052
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
12477016
Citation
Young G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens wearers. Ophthalmic Physiol Opt. 2002 Nov;22(6):516-27. doi: 10.1046/j.1475-1313.2002.00066.x.
Results Reference
background
PubMed Identifier
18538404
Citation
Stapleton F, Keay L, Edwards K, Naduvilath T, Dart JK, Brian G, Holden BA. The incidence of contact lens-related microbial keratitis in Australia. Ophthalmology. 2008 Oct;115(10):1655-62. doi: 10.1016/j.ophtha.2008.04.002. Epub 2008 Jun 5.
Results Reference
background
PubMed Identifier
30907859
Citation
Jong M, Tilia D, Sha J, Diec J, Thomas V, Bakaraju RC. The Relationship between Visual Acuity, Subjective Vision, and Willingness to Purchase Simultaneous-image Contact Lenses. Optom Vis Sci. 2019 Apr;96(4):283-290. doi: 10.1097/OPX.0000000000001359.
Results Reference
derived
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Dispensing Study to Assess Visual Performance of Prototype Contact Lenses
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