Back to resultsClinical Evaluation of Two Silicone Hydrogel Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lens A (comfilcon A lens)
Lens B (lehfilcon A lens)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- They are aged 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 have successfully worn contact lenses within six months of starting the study.
- They can be satisfactorily fitted with the study contact lenses.
- They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction.
- They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction.
- They own and habitually wear single vision spectacles.
- They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses.
- They agree not to participate in other clinical research while enrolled on this study.
Exclusion Criteria:
- 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 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 or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction.
- They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
- They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work.
Sites / Locations
- Eurolens Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lens A, Then Lens B
Lens B, Then Lens A
Arm Description
Participants will wear Lens A for six hours and then cross over to wear Lens B for six hours.
Participants will wear Lens B for six hours and then cross over to wear Lens A for six hours.
Outcomes
Primary Outcome Measures
Ease of Lens Insertion
Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05313412
Brief Title
Clinical Evaluation of Two Silicone Hydrogel Contact Lenses
Official Title
Clinical Evaluation of Two Silicone Hydrogel Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 27, 2022 (Actual)
Primary Completion Date
April 21, 2022 (Actual)
Study Completion Date
April 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
This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses.
Detailed Description
This is a double-masked, randomized, bilateral crossover study to compare the short-term clinical performance of two silicone hydrogel soft contact lenses. Each lens type is worn for approximately six hours on separate study days, in random sequence.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lens A, Then Lens B
Arm Type
Experimental
Arm Description
Participants will wear Lens A for six hours and then cross over to wear Lens B for six hours.
Arm Title
Lens B, Then Lens A
Arm Type
Experimental
Arm Description
Participants will wear Lens B for six hours and then cross over to wear Lens A for six hours.
Intervention Type
Device
Intervention Name(s)
Lens A (comfilcon A lens)
Intervention Description
6 hours
Intervention Type
Device
Intervention Name(s)
Lens B (lehfilcon A lens)
Intervention Description
6 hours
Primary Outcome Measure Information:
Title
Ease of Lens Insertion
Description
Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)
Time Frame
6 hours
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.
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 have successfully worn contact lenses within six months of starting the study.
They can be satisfactorily fitted with the study contact lenses.
They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction.
They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction.
They own and habitually wear single vision spectacles.
They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses.
They agree not to participate in other clinical research while enrolled on this study.
Exclusion Criteria:
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 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 or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction.
They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Morgan, PhD,MCOptom
Organizational Affiliation
Eurolens Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurolens Research
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Two Silicone Hydrogel Contact Lenses
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