Back to resultsA Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hema-copolymer Lens
etafilcon A Lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
Subjects will only be eligible for the study if:
- They are 18 years of age and above.
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They agree not to participate in other clinical research for the duration of this study.
- They can attain at least 6/9 in each eye with the study lenses within the available power range.
- They can be fitted with study lenses within the available power range.
- The currently use soft contact lenses, or have done so within the last six months.
Exclusion Criteria:
Subjects will not be able to take part in the study if:
- They have an ocular disorder which would normally contraindicate contact lens wear.
- They have a systemic disorder which would normally contraindicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They have had cataract surgery.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- They are pregnant or lactating.
- They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- They have any infectious disease which would normally contraindicate contact lens wear, or may, in the opinion of the investigator, pose a risk to study personnel; or any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reactions.
- They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Sites / Locations
- Eurolens Research - The University of Manchester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hema-copolymer Lens
etafilcon A Lens
Arm Description
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
Outcomes
Primary Outcome Measures
Visual Acuity - Hema-copolymer and Etafilcon A
Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.
Visual Acuity - Hema-copolymer and Etafilcon A
Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.
Biomicroscopy - Hema-copolymer and Etafilcon A
Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01965262
Brief Title
A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens
Official Title
A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.
Detailed Description
This is a subject-masked, dispensing study designed to evaluate the clinical performance and subjective acceptance when comparing two different daily disposable limbal ring lenses. Limbal ring lenses, which as well as correcting vision, have a colored ring which enhance the wearer's iris and are particularly popular in East Asian countries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hema-copolymer Lens
Arm Type
Active Comparator
Arm Description
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Arm Title
etafilcon A Lens
Arm Type
Active Comparator
Arm Description
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
Intervention Type
Device
Intervention Name(s)
Hema-copolymer Lens
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
etafilcon A Lens
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Visual Acuity - Hema-copolymer and Etafilcon A
Description
Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.
Time Frame
Baseline
Title
Visual Acuity - Hema-copolymer and Etafilcon A
Description
Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.
Time Frame
1 week
Title
Biomicroscopy - Hema-copolymer and Etafilcon A
Description
Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).
Time Frame
1 week
Title
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Description
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Time Frame
Baseline
Title
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Description
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Time Frame
1 week
Title
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Description
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Time Frame
Baseline
Title
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Description
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Time Frame
1 week
Title
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Description
Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Time Frame
Baseline
Title
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Description
Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Time Frame
1 week
Title
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Description
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Time Frame
Baseline
Title
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Description
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Time Frame
1 week
Title
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Description
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Time Frame
Baseline
Title
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Description
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Time Frame
1 week
Title
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Description
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time Frame
Baseline
Title
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Description
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time Frame
1 week
Title
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Description
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time Frame
Baseline
Title
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Description
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time Frame
1 week
Title
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.
Time Frame
Baseline
Title
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.
Time Frame
1 week
Title
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Time Frame
Baseline
Title
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Time Frame
1 week
Title
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Time Frame
Baseline
Title
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Time Frame
1 week
Title
Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Time Frame
1 week
Title
Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.
Time Frame
1 week
Title
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Time Frame
Baseline
Title
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Time Frame
1 week
Title
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Time Frame
Baseline
Title
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Description
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will only be eligible for the study if:
They are 18 years of age and above.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They agree not to participate in other clinical research for the duration of this study.
They can attain at least 6/9 in each eye with the study lenses within the available power range.
They can be fitted with study lenses within the available power range.
The currently use soft contact lenses, or have done so within the last six months.
Exclusion Criteria:
Subjects will not be able to take part in the study if:
They have an ocular disorder which would normally contraindicate contact lens wear.
They have a systemic disorder which would normally contraindicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract surgery.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
They are pregnant or lactating.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
They have any infectious disease which would normally contraindicate contact lens wear, or may, in the opinion of the investigator, pose a risk to study personnel; or any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reactions.
They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole Maldonado-Codinal, PhD
Organizational Affiliation
Eurolens Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurolens Research - The University of Manchester
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens
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