Back to resultsQuantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Soft Toric Custom Made Contact lens
Soft Spherical Contact Lenses
Spectacle Correction
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
Inclusion Criteria:
-
Subjects will only be eligible for the study if:
- They are of legal age between 18 and 40 years.
- 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 current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
- They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
- They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
- They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range.
- 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 this study.
Exclusion Criteria:
-
Subjects will not be eligible to take part in the study if:
- 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 or ointment.
- 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 an amblyopic eye, in which case only dominant eye will be assessed for that subject.
- They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.
- They have a history of severe allergic reaction or anaphylaxis.
- They have taken part in any other contact lens 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 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Soft Toric Custom Made contact lenses
Soft Spherical Contact Lenses
Spectacle Correction
Arm Description
Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched.
Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched
Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Outcomes
Primary Outcome Measures
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Secondary Outcome Measures
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention.
Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Slit Lamp Biomicroscopy Findings - Limbal Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Slit Lamp Biomicroscopy Findings - Limbal Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Slit Lamp Biomicroscopy Findings - Corneal Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Slit Lamp Biomicroscopy Findings - Corneal Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention.
Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention.
Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention.
Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Slit Lamp Biomicroscopy Findings - Corneal Oedema
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Slit Lamp Biomicroscopy Findings - Corneal Oedema
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention.
Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Full Information
NCT ID
NCT04613882
First Posted
October 28, 2020
Last Updated
September 19, 2023
Sponsor
Coopervision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04613882
Brief Title
Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses
Official Title
Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 21, 2022 (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 aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.
Detailed Description
This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Soft Toric Custom Made contact lenses
Arm Type
Experimental
Arm Description
Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched.
Arm Title
Soft Spherical Contact Lenses
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched
Arm Title
Spectacle Correction
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Intervention Type
Device
Intervention Name(s)
Soft Toric Custom Made Contact lens
Intervention Description
Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched.
Intervention Type
Device
Intervention Name(s)
Soft Spherical Contact Lenses
Intervention Description
Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched.
Intervention Type
Device
Intervention Name(s)
Spectacle Correction
Intervention Description
Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Visual acuity was assessed using logMAR for each intervention.
Time Frame
Baseline with low contrast VA
Title
Visual Acuity
Description
Visual acuity was assessed using logMAR for each intervention.
Time Frame
After 30 minutes of dispense (Low Contrast VA)
Title
Visual Acuity
Description
Visual acuity was assessed using logMAR for each intervention.
Time Frame
Baseline with High contrast VA
Title
Visual Acuity
Description
Visual acuity was assessed using logMAR for each intervention.
Time Frame
After 30 minutes of dispense (High Contrast VA)
Secondary Outcome Measure Information:
Title
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention.
Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time Frame
Entrance (Prior to wear of study lens)
Title
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time Frame
At Exit (After 30 minutes in each of three interventions)
Title
Slit Lamp Biomicroscopy Findings - Limbal Redness
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time Frame
Entrance (Prior to wear of study lens)
Title
Slit Lamp Biomicroscopy Findings - Limbal Redness
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time Frame
At Exit (After 30 minutes in each of three interventions)
Title
Slit Lamp Biomicroscopy Findings - Corneal Staining
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time Frame
Entrance (Prior to wear of study lens)
Title
Slit Lamp Biomicroscopy Findings - Corneal Staining
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time Frame
At Exit (After 30 minutes in each of three interventions)
Title
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention.
Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time Frame
Entrance (Prior to wear of study lens)
Title
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time Frame
At Exit (After 30 minutes in each of three interventions)
Title
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention.
Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time Frame
Entrance (Prior to wear of study lens)
Title
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention.
Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time Frame
At Exit (After 30 minutes in each of three interventions)
Title
Slit Lamp Biomicroscopy Findings - Corneal Oedema
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time Frame
Entrance (Prior to wear of study lens)
Title
Slit Lamp Biomicroscopy Findings - Corneal Oedema
Description
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention.
Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time Frame
At Exit (After 30 minutes in each of three interventions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-
Subjects will only be eligible for the study if:
They are of legal age between 18 and 40 years.
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 current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range.
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 this study.
Exclusion Criteria:
-
Subjects will not be eligible to take part in the study if:
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 or ointment.
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 an amblyopic eye, in which case only dominant eye will be assessed for that subject.
They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.
They have a history of severe allergic reaction or anaphylaxis.
They have taken part in any other contact lens clinical trial or research, within two weeks prior to starting this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Read
Organizational Affiliation
Eurolens Research
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
Learn more about this trial
Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses
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