Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
Study Details
Study Description
Brief Summary
This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
| N/A |
Detailed Description
This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Comfilcon A lens (test) Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study. | Device: Comfilcon A lens (test) contact lens
Other Names: |
Active Comparator: Omafilcon B Lens (control) Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study. | Device: Omafilcon B lens (control) contact lens
Other Names: |
Outcome Measures
Primary Outcome Measures
- Visual Acuity [up to 3 hours]
Visual acuity is assessed for test and control lens on a logMAR chart
Secondary Outcome Measures
- Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity [up to 3 hours]
Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
- Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity [up to 3 hours]
Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
- Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity [up to 3 hours]
Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Has had a self-reported oculo-visual examination in the last two years.
-
Is between ages 40-75 years, inclusive and has full legal capacity to volunteer.
-
Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule.
-
Is able to participate in Parts A and B related to this work.
-
Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).
-
Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
-
Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
-
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.
-
Currently wears soft contact lenses.
-
Has clear corneas and no active ocular disease.
-
Has not worn lenses for at least 12 hours before the examination.
Exclusion Criteria:
A person will be excluded from the study if he/she:
-
Has never worn contact lenses before.
-
Has any systemic disease affecting ocular health.
-
Is using any systemic or topical medications that will affect ocular health.
-
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
-
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
-
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
-
Is aphakic.
-
Has undergone corneal refractive surgery.
-
Is participating in any other type of eye related clinical or research study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University | Bloomington | Indiana | United States | 47405 |
Sponsors and Collaborators
- Coopervision, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- CV-18-10
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Three subjects did not meet the inclusion criteria. Seventeen (17) subjects completed all visits and were included in the analysis. |
Arm/Group Title | Comfilcon A Lens Then Omafilcon B Lens | Omafilcon B Lens Then Comfilcon A |
---|---|---|
Arm/Group Description | Subjects are randomized to wear comfilcon A lens for up to 3 hours then omafilcon B lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lens | Subjects are randomized to wear omafilcon B lens for up to 3 hours then comfilcon A lens up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens |
Period Title: 1st Intervention (3 Hours) | ||
STARTED | 8 | 9 |
COMPLETED | 8 | 9 |
NOT COMPLETED | 0 | 0 |
Period Title: 1st Intervention (3 Hours) | ||
STARTED | 9 | 8 |
COMPLETED | 9 | 8 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Comfilcon A Lens (Test) and Omafilcon B (Control) |
---|---|
Arm/Group Description | Subjects were randomized to wear the comfilcon A (test) or omafilcon B (control) lens for up to 3 hours, either as first or second lens during this cross over study. |
Overall Participants | 17 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] | 54
(7)
|
Sex: Female, Male (Count of Participants) | |
Female | 11 64.7% |
Male | 6 35.3% |
Race and Ethnicity Not Collected (Count of Participants) | |
Region of Enrollment (participants) [Number] | |
United States | 17 100% |
Outcome Measures
Title | Visual Acuity |
---|---|
Description | Visual acuity is assessed for test and control lens on a logMAR chart |
Time Frame | up to 3 hours |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Lens (Test) | Omafilcon B Lens (Control) |
---|---|---|
Arm/Group Description | Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lens | Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens |
Measure Participants | 17 | 17 |
Distance: Binocular | -0.01
(0.09)
| -0.03
(0.16)
|
Distance: Monocular (dominate eye) | -0.05
(0.12)
| 0.06
(0.21)
|
Distant: Monocular (non-dominate eye) | 0.02
(0.13)
| 0.13
(0.22)
|
Near: Binocular | 0.05
(0.09)
| 0.03
(0.07)
|
Near: Monocular (dominate eye) | 0.14
(0.11)
| 0.17
(0.13)
|
Near: Monocular (non-dominate eye) | 0.10
(0.13)
| 0.04
(0.18)
|
Title | Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity |
---|---|
Description | Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. |
Time Frame | up to 3 hours |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Lens (Test) | Omafilcon B Lens (Control) |
---|---|---|
Arm/Group Description | Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lens | Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens |
Measure Participants | 17 | 17 |
Mean (Standard Deviation) [units on a scale] | 91
(8)
| 79
(24)
|
Title | Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity |
---|---|
Description | Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. |
Time Frame | up to 3 hours |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Lens (Test) | Omafilcon B Lens (Control) |
---|---|---|
Arm/Group Description | Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lens | Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens |
Measure Participants | 17 | 17 |
Mean (Standard Deviation) [units on a scale] | 87
(12)
| 82
(17)
|
Title | Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity |
---|---|
Description | Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. |
Time Frame | up to 3 hours |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Lens (Test) | Omafilcon B Lens (Control) |
---|---|---|
Arm/Group Description | Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lens | Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens |
Measure Participants | 17 | 17 |
Mean (Standard Deviation) [units on a scale] | 84
(17)
| 79
(26)
|
Adverse Events
Time Frame | Up to 3 hours per intervention. | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Comfilcon A Lens (Test) | Omafilcon B Lens (Control) | ||
Arm/Group Description | Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study. Comfilcon A lens (test): contact lens | Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study. Omafilcon B lens (control): contact lens | ||
All Cause Mortality | ||||
Comfilcon A Lens (Test) | Omafilcon B Lens (Control) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/17 (0%) | 0/17 (0%) | ||
Serious Adverse Events | ||||
Comfilcon A Lens (Test) | Omafilcon B Lens (Control) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/17 (0%) | 0/17 (0%) | ||
Other (Not Including Serious) Adverse Events | ||||
Comfilcon A Lens (Test) | Omafilcon B Lens (Control) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/17 (0%) | 0/17 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Myhanh Nguyen, Sr. Optometrist |
---|---|
Organization | CooperVision |
Phone | 19257306716 |
MNguyen@coopervision.com |
- CV-18-10