- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03006458
A Clinical Comparison of 2 Multifocal Toric XR (Extended Range) Contact Lenses
A Clinical Comparison of the Comfilcon A (Extended Range) XR Toric Multifocal and Omafilcon B Toric XR Multifocal Contact Lenses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Thirty subjects will use each lens type for two weeks in random sequence. Follow-up visits for each lens will be performed after two weeks of wear. Lenses will be worn on a daily wear basis.
The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Manchester, United Kingdom, M13 9PL
- Eurolens Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects will only be eligible for the study if:
- They are aged 40 - 70 years, inclusive.
- 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 completed the non-dispensing study (C16-597) as the lenses to be worn on this study (C16-599) are predetermined from their participation on study C16-597.
- They have a contact lens spherical prescription between +10.00 to -10.00D (Diopters) (inclusive).
- They have astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
They have an Add component to their spectacle refraction (between +0.75 and
+2.50DS).
- They can be satisfactorily fitted with the study lenses.
- They can attain at least 0.30 logMAR binocular distance high contrast visual acuity with the study lenses within the available power range.
- They have successfully worn soft contact lenses in the last two years.
- They are willing to comply with the wear schedule (at least five days per week and for at least six hours per day).
- They agree not to participate in other clinical research for the duration of this study.
- They own a wearable pair of spectacles.
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 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 breast-feeding.
- They have any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. ≥ Grade 3 finding of oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the Efron classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
- They have any infectious disease (e.g. hepatitis) 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).
- They have 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: comfilcon A
Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design. |
toric contact lens
|
Active Comparator: omafilcon B
Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.
|
toric contact lens
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stability
Time Frame: Baseline
|
Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
|
Baseline
|
Stability
Time Frame: 2 weeks
|
Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
|
2 weeks
|
Overall Toric Lens Fit Acceptance
Time Frame: Baseline
|
Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses.
Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
|
Baseline
|
Overall Toric Lens Fit Acceptance
Time Frame: 2 weeks
|
Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses.
Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
|
2 weeks
|
Comfort
Time Frame: Baseline
|
Subjective ratings for comfort assessed.
Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
|
Baseline
|
Comfort
Time Frame: 2 weeks
|
Subjective ratings for comfort assessed.
Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
|
2 weeks
|
Overall Satisfaction
Time Frame: 2 weeks
|
Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed.
Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied
|
2 weeks
|
Dryness
Time Frame: 2 weeks
|
Subjective ratings for dryness assessed.
Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time
|
2 weeks
|
Visual Fluctuation/ Stability
Time Frame: 2 weeks
|
Subjective ratings for visual fluctuation/stability assessed.
Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing
|
2 weeks
|
Handling
Time Frame: 2 weeks
|
Subjective ratings for handling difficulty assessed at 2 weeks.
Scale 0-100, 0=very difficult, 100=very easy
|
2 weeks
|
Quality of Near Vision
Time Frame: 2 weeks
|
Subjective ratings for quality of near vision.
Scale 0-100, 0=extremely poor vision all of the time.
cannot function, 100 - excellent vision all of the time.
|
2 weeks
|
Quality of Intermediate Vision
Time Frame: 2 weeks
|
Subjective ratings for quality of intermediate vision.
Scale 0-100, 0=extremely poor vision all of the time.
cannot function, 100 - excellent vision all of the time.
|
2 weeks
|
Quality of Distance Vision
Time Frame: 2 weeks
|
Subjective ratings for quality of distance vision.
Scale 0-100, 0=extremely poor vision all of the time.
cannot function, 100 - excellent vision all of the time.
|
2 weeks
|
Quality of Vision While Driving During the Day
Time Frame: 2 weeks
|
Subjective rating for quality of vision while driving during the day.
Scale 0-100, 0=extremely poor vision all of the time.
cannot function, 100 - excellent vision all of the time.
|
2 weeks
|
Quality of Vision While Driving During the Night
Time Frame: 2 weeks
|
Subjective ratings for quality of vision while driving at night.
Scale 0-100, 0=extremely poor vision all of the time.
cannot function, 100 - excellent vision all of the time.
|
2 weeks
|
Ghosting at Near
Time Frame: 2 weeks
|
Subjective ratings for ghosting at near assessed at 2 weeks.
Scale 0-100, 0=intolerable, 100=not noticeable.
|
2 weeks
|
Ghosting at Distance
Time Frame: 2 weeks
|
Subjective ratings for ghosting at distance assessed at 2 weeks.
Scale 0-100, 0=intolerable, 100=not noticeable.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV-16-28 (C16-599)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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