Back to resultsVision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
Primary Purpose
Astigmatism, Myopia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Test Contact lens
Control Contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
Inclusion Criteria:
- They are aged 18-35 years and have capacity to volunteer.
- 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 are an existing wearer of soft spherical contact lenses in both eyes.
They have a spherical component of their spectacle refractive error between
-0.50DS and -6.50DS in both eyes.
They have a cylindrical component of their spectacle refractive error between
-0.75DC and -1.25DC in both eyes.
- They can be fitted satisfactorily with both lens types.
- They own an acceptable pair of spectacles.
- They agree not to participate in other clinical research for the duration of the study.
Exclusion Criteria:
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops (including comfort drops) or ointment on a regular basis.
- They are aphakic.
- 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 breastfeeding.
- 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, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Sites / Locations
- Eurolens Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Contact lens
Control Contact lens
Arm Description
Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
Outcomes
Primary Outcome Measures
Vision Stability While Doing Tasks on Mobile Phone
Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Vision Stability While Doing Tasks on Desktop
Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Vision Stability While Walking
Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Secondary Outcome Measures
Lens Fit for Test Contact Lens
Lens fit was assessed for lens rotation after 10 minutes for toric fit. Lens mislocation from optimal position was measured in 0°, 1-5°, 6-10°, 11-15°, 16-20°, More than 20°.
Lens Fit
Lens fit was assessed as either 'acceptable' or 'not acceptable' for standard fit by study investigator.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04536571
Brief Title
Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
Official Title
Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
June 7, 2021 (Actual)
Study Completion Date
June 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The principal hypothesis is to be tested in this work is that vision stability (the primary outcome measure) with a spherical contact lens correction vs. a toric contact lens correction will be the same.
Detailed Description
This will be a randomised, subject-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Thirty subjects will use each lens type at a single visit in random sequence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism, Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Contact lens
Arm Type
Experimental
Arm Description
Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
Arm Title
Control Contact lens
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
Intervention Type
Device
Intervention Name(s)
Test Contact lens
Other Intervention Name(s)
Soft comfilcon A toric contact lenses
Intervention Description
Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
Intervention Type
Device
Intervention Name(s)
Control Contact lens
Other Intervention Name(s)
Soft comfilcon A sphere contact lenses
Intervention Description
Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
Primary Outcome Measure Information:
Title
Vision Stability While Doing Tasks on Mobile Phone
Description
Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Time Frame
30 minutes
Title
Vision Stability While Doing Tasks on Desktop
Description
Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Time Frame
30 minutes
Title
Vision Stability While Walking
Description
Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Lens Fit for Test Contact Lens
Description
Lens fit was assessed for lens rotation after 10 minutes for toric fit. Lens mislocation from optimal position was measured in 0°, 1-5°, 6-10°, 11-15°, 16-20°, More than 20°.
Time Frame
10 minutes
Title
Lens Fit
Description
Lens fit was assessed as either 'acceptable' or 'not acceptable' for standard fit by study investigator.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
They are aged 18-35 years and have capacity to volunteer.
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 are an existing wearer of soft spherical contact lenses in both eyes.
They have a spherical component of their spectacle refractive error between
-0.50DS and -6.50DS in both eyes.
They have a cylindrical component of their spectacle refractive error between
-0.75DC and -1.25DC in both eyes.
They can be fitted satisfactorily with both lens types.
They own an acceptable pair of spectacles.
They agree not to participate in other clinical research for the duration of the study.
Exclusion Criteria:
They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops (including comfort drops) or ointment on a regular basis.
They are aphakic.
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 breastfeeding.
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, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Morgan, PhD.
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurolens Research
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
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