Back to resultsDispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
Primary Purpose
Presbyopia, Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Etafilcon A
Etafilcon A
Nelfilcon A
Nesofilcon A
Nelfilcon A
Etafilcon A
Somofilcon A
58% Poly-HEMA
Omafilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, Refractive error, Contact lens
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.
- 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.
Sites / Locations
- Brien Holden Vision Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Presbyope group
Non-Presbyope group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale
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
Subjective rating of vision on a 1-10 visual analogue scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02484586
Brief Title
Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
Official Title
Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
February 7, 2017 (Actual)
Study Completion Date
February 7, 2017 (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 the visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses.
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.
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 lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Presbyope group
Arm Type
Other
Arm Description
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.
Arm Title
Non-Presbyope group
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Etafilcon A
Intervention Description
Prototype lens material
Intervention Type
Device
Intervention Name(s)
Etafilcon A
Other Intervention Name(s)
1-Day Acuvue Moist Multifocal
Intervention Description
Control lens for presbyope group
Intervention Type
Device
Intervention Name(s)
Nelfilcon A
Other Intervention Name(s)
Dailies Aqua Comfort Plus Multifocal
Intervention Description
Control lens for presbyope group
Intervention Type
Device
Intervention Name(s)
Nesofilcon A
Other Intervention Name(s)
Biotrue ONEday for Presbyopia
Intervention Description
Control lens for presbyope group
Intervention Type
Device
Intervention Name(s)
Nelfilcon A
Other Intervention Name(s)
Dailies Aqua Comfort Plus
Intervention Description
Control lens for non-presbyope group
Intervention Type
Device
Intervention Name(s)
Etafilcon A
Other Intervention Name(s)
1-Day Acuvue Moist
Intervention Description
Control lens for non-presbyope group
Intervention Type
Device
Intervention Name(s)
Somofilcon A
Other Intervention Name(s)
Clariti 1 Day Multifocal
Intervention Description
Control lens for presbyope group
Intervention Type
Device
Intervention Name(s)
58% Poly-HEMA
Other Intervention Name(s)
SEED 1dayPure moisture Multistage
Intervention Description
Control lens for presbyope group
Intervention Type
Device
Intervention Name(s)
Omafilcon A
Other Intervention Name(s)
Proclear Multifocal
Intervention Description
Control lens for non-presbyope group
Primary Outcome Measure Information:
Title
Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale
Description
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.
Time Frame
Approximately 1 week after lens fitting
Secondary Outcome Measure Information:
Title
Subjective rating of vision on a 1-10 visual analogue scale
Description
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.
Time Frame
Approximately 1 week after lens fitting
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Sha, BOptom/BSc
Organizational Affiliation
Brien Holden Vision Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brien Holden Vision Institute
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2052
Country
Australia
12. IPD Sharing Statement
Citations:
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
PubMed Identifier
30451806
Citation
Sha J, Tilia D, Kho D, Amrizal H, Diec J, Yeotikar N, Jong M, Thomas V, Bakaraju RC. Visual Performance of Daily-disposable Multifocal Soft Contact Lenses: A Randomized, Double-blind Clinical Trial. Optom Vis Sci. 2018 Dec;95(12):1096-1104. doi: 10.1097/OPX.0000000000001311.
Results Reference
derived
Learn more about this trial
Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
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