The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
Primary Purpose
Astigmatism, Myopia
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lens A (Test)
Lens B (control)
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
Inclusion Criteria:
- They are aged between 18 and 40 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 currently wear soft contact lenses or have done so in the past two years.
- They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
- They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).
- They can be satisfactorily fitted with the study lens types.
- At dispensing, they can attain at least 6/12 distance high contrast visual acuity in each eye with the study lenses within the available power range.
- They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
- They own a wearable pair of spectacles.
- They agree not to participate in other clinical research while enrolled on this 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 or ointment.
- 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 eye or health conditions including immunosuppressive or infectious diseases, which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
- They are currently wearing one of the study contact lenses.
- 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
- Cameron Optometry
- Simon Falk Eyecare
- Phipps Opticians
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lens A (Test)
Lens B (Control)
Arm Description
Subjects will be randomized to wear Lens A (Test) toric lens for one week.
Subjects will be randomized to wear Lens B (control) toric lens for one week.
Outcomes
Primary Outcome Measures
Subjective handling ratings on lens removal
Subjective handling ratings on lens removal will be measured on a scale of 0-100 (0- Unmanageable, 20- Very poor , 40 - Poor, 60- Good, 80- Very good, 100- Excellent unsuccessful removal, 40 -
Secondary Outcome Measures
Lens Fit - Horizontal Centration
Lens Fit - Horizontal Centration will be measured on a five point scale -2 to +2 (-2 Extremely nasal, -1 Slightly nasal, 0 = Optimum, +1 Slightly temporal, +2 Extremely temporal)
Lens Fit - Vertical centration
Lens Fit - Vertical Centration will be measured on a five point scale of -2 to +2 (-2 Extremely inferior, -1 Slightly inferior, 0= Optimum, +1 Slightly Superior, +2 Extremely Superior)
Corneal Coverage
Corneal Coverage will be measured on a five point scale 0f -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)
Lens Movement
Lens Movement will be measured on a five point scale of -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05020990
Brief Title
The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
Official Title
The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
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
Yes
5. Study Description
Brief Summary
This study aims to compare the clinical performance of two daily disposable toric contact lenses.
Detailed Description
This will be a multi-centre, randomised, open-label, crossover, bilateral study, controlled by cross-comparison. Up to 55 subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear.
Lenses will be worn on a daily wear, daily disposable wear schedule.
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
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lens A (Test)
Arm Type
Experimental
Arm Description
Subjects will be randomized to wear Lens A (Test) toric lens for one week.
Arm Title
Lens B (Control)
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear Lens B (control) toric lens for one week.
Intervention Type
Device
Intervention Name(s)
Lens A (Test)
Intervention Description
Test toric lens
Intervention Type
Device
Intervention Name(s)
Lens B (control)
Intervention Description
Control toric lens
Primary Outcome Measure Information:
Title
Subjective handling ratings on lens removal
Description
Subjective handling ratings on lens removal will be measured on a scale of 0-100 (0- Unmanageable, 20- Very poor , 40 - Poor, 60- Good, 80- Very good, 100- Excellent unsuccessful removal, 40 -
Time Frame
One week.
Secondary Outcome Measure Information:
Title
Lens Fit - Horizontal Centration
Description
Lens Fit - Horizontal Centration will be measured on a five point scale -2 to +2 (-2 Extremely nasal, -1 Slightly nasal, 0 = Optimum, +1 Slightly temporal, +2 Extremely temporal)
Time Frame
One Week
Title
Lens Fit - Vertical centration
Description
Lens Fit - Vertical Centration will be measured on a five point scale of -2 to +2 (-2 Extremely inferior, -1 Slightly inferior, 0= Optimum, +1 Slightly Superior, +2 Extremely Superior)
Time Frame
One week
Title
Corneal Coverage
Description
Corneal Coverage will be measured on a five point scale 0f -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)
Time Frame
One week
Title
Lens Movement
Description
Lens Movement will be measured on a five point scale of -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)
Time Frame
One week
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:
They are aged between 18 and 40 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 currently wear soft contact lenses or have done so in the past two years.
They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).
They can be satisfactorily fitted with the study lens types.
At dispensing, they can attain at least 6/12 distance high contrast visual acuity in each eye with the study lenses within the available power range.
They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
They own a wearable pair of spectacles.
They agree not to participate in other clinical research while enrolled on this 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 or ointment.
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 eye or health conditions including immunosuppressive or infectious diseases, which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
They are currently wearing one of the study contact lenses.
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
Organizational Affiliation
Eurolens Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cameron Optometry
City
Edinburgh
State/Province
Edinburg
ZIP/Postal Code
EH3 6SW
Country
United Kingdom
Facility Name
Simon Falk Eyecare
City
Oakwood
State/Province
Leeds
ZIP/Postal Code
LS8 2HU
Country
United Kingdom
Facility Name
Phipps Opticians
City
Heckmondwike
ZIP/Postal Code
WF16 0EZ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
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