A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Study Details
Study Description
Brief Summary
The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: comfilcon A Extended Range test lens Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. |
Device: comfilcon A Extended Range test lens
contact lens
Device: comfilcon A control lens
contact lens
|
Active Comparator: comfilcon A control lens Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. |
Device: comfilcon A Extended Range test lens
contact lens
Device: comfilcon A control lens
contact lens
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity [4 days]
Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR.
- Visual Performance [4 days]
Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).
Secondary Outcome Measures
- Subjective Ratings for Comfort [Baseline]
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
- Subjective Ratings for Comfort [4 days]
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
- Subjective Ratings for Dryness [Baseline]
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
- Subjective Ratings for Dryness [4 days]
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
- Lens Handling [4 Days]
Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle).
- Average Daily Wearing Time [4 days]
Average daily wearing time for test and control lens is assessed in hours.
- Lens Fit [4 days]
Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit.
- Bulbar Hyperemia [4 days]
Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
- Limbal Hyperemia [4 days]
Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
- Subjective Satisfaction [4 days]
Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied)
- Subjective Preference for Near Vision [4 days]
Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction.
- Subjective Preference for Distance Vision [4 days]
Subjective preference for distance vision for test and control contact lenses.
- Subjective Preference for Intermediate Vision [4 days]
Subjective preference for intermediate vision for test and control contact lenses.
- Subjective Preference for Overall Vision [4 days]
Subjective preference for overall vision for test and control contact lenses.
- Subjective Preference for Comfort [4 days]
Subjective preference for comfort for test and control contact lenses.
- Subjective Overall Lens Preference [4 days]
Subjective overall lens preference for test and control contact lenses.
Eligibility Criteria
Criteria
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
-
Has had a self-reported oculo-visual examination in the last two years
-
Is 50 years of age or greater and has full legal capacity to volunteer
-
Is able to read and understand the informed consent
-
Is willing and able to follow instructions and maintain the appointment schedule
-
Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
-
Near Add Power requirement of +2.25D or greater
-
Has spectacle cylinder 0.75 D in both eyes
-
Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
-
Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
-
Has clear corneas and no active ocular disease
-
Has not worn gas permeable contact lenses for 1 month prior to the study
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 abnormality that would affect the wearing of contact lenses
-
Is aphakic (i.e. missing their natural lens inside their eye)
-
Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
-
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 | CORL, Indiana University | Bloomington | Indiana | United States | 47405 |
Sponsors and Collaborators
- Coopervision, Inc.
Investigators
- Principal Investigator: Pete S Kollbaum, O.D., Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CV-16-02
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Test Lens Then Control Lens | Control Lens Then Test Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses then control contact lenses bilaterally for four days in the cross-over study. comfilcon A Extended Range test lens: contact lenses comfilcon A control lens: contact lenses | Subjects will be randomized to wear the control contact lenses then test contact lenses bilaterally for four days in the cross-over study. comfilcon A control lens: contact lenses comfilcon A Extended Range test lens: contact lenses |
Period Title: First Intervention | ||
STARTED | 7 | 7 |
COMPLETED | 7 | 6 |
NOT COMPLETED | 0 | 1 |
Period Title: First Intervention | ||
STARTED | 7 | 6 |
COMPLETED | 7 | 6 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses or control contact lenses first as per the randomization table bilaterally for four days then cross-over to alternated pair lenses. comfilcon A Extended Range test lens: contact lenses comfilcon A control lens: contact lenses |
Overall Participants | 14 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
14
100%
|
>=65 years |
0
0%
|
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
57
(7)
|
Sex: Female, Male (Count of Participants) | |
Female |
13
92.9%
|
Male |
1
7.1%
|
Race and Ethnicity Not Collected (Count of Participants) | |
Region of Enrollment (participants) [Number] | |
United States |
14
100%
|
Outcome Measures
Title | Visual Acuity |
---|---|
Description | Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR. |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Distance |
-0.01
(0.09)
|
-0.07
(0.10)
|
Intermediate |
-0.15
(0.16)
|
-0.13
(0.10)
|
Near |
-0.02
(0.09)
|
0.01
(0.07)
|
Title | Visual Performance |
---|---|
Description | Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time). |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Distance |
72
(19)
|
77
(20)
|
Intermediate |
85
(17)
|
88
(13)
|
Near |
79
(23)
|
80
(16)
|
Title | Subjective Ratings for Comfort |
---|---|
Description | Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [units on a scale] |
96
(8)
|
91
(6)
|
Title | Subjective Ratings for Comfort |
---|---|
Description | Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [units on a scale] |
87
(21)
|
89
(17)
|
Title | Subjective Ratings for Dryness |
---|---|
Description | Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [units on a scale] |
94
(9)
|
94
(7)
|
Title | Subjective Ratings for Dryness |
---|---|
Description | Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [units on a scale] |
83
(23)
|
88
(14)
|
Title | Lens Handling |
---|---|
Description | Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle). |
Time Frame | 4 Days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [units on a scale] |
89
(25)
|
95
(9)
|
Title | Average Daily Wearing Time |
---|---|
Description | Average daily wearing time for test and control lens is assessed in hours. |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [Hours/day] |
10
(2)
|
9
(3)
|
Title | Lens Fit |
---|---|
Description | Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit. |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [units on a scale] |
3.3
(0.4)
|
3.3
(0.3)
|
Title | Bulbar Hyperemia |
---|---|
Description | Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [units on a scale] |
0.88
(0.44)
|
0.89
(0.42)
|
Title | Limbal Hyperemia |
---|---|
Description | Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [units on a scale] |
0.13
(0.26)
|
0.18
(0.28)
|
Title | Subjective Satisfaction |
---|---|
Description | Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied) |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens |
Measure Participants | 13 | 13 |
Mean (Standard Deviation) [units on a scale] |
71
(23)
|
74
(19)
|
Title | Subjective Preference for Near Vision |
---|---|
Description | Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction. |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | Subjects were randomized to wear test lens or control contact lenses bilaterally for four days in this cross-over study. |
Measure Participants | 13 |
Test |
4
28.6%
|
No Preference |
4
28.6%
|
Control |
5
35.7%
|
Title | Subjective Preference for Distance Vision |
---|---|
Description | Subjective preference for distance vision for test and control contact lenses. |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | Subjects were randomized to wear test lens or control contact lenses bilaterally for four days in this cross-over study. |
Measure Participants | 13 |
Test |
3
21.4%
|
No Preference |
2
14.3%
|
Control |
8
57.1%
|
Title | Subjective Preference for Intermediate Vision |
---|---|
Description | Subjective preference for intermediate vision for test and control contact lenses. |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | Subjects were randomized to wear test lens or control contact lenses bilaterally for four days in this cross-over study. |
Measure Participants | 13 |
Test |
3
21.4%
|
No Preference |
4
28.6%
|
Control |
6
42.9%
|
Title | Subjective Preference for Overall Vision |
---|---|
Description | Subjective preference for overall vision for test and control contact lenses. |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | Subjects were randomized to wear test lens or control contact lenses bilaterally for four days in this cross-over study. |
Measure Participants | 13 |
Test |
3
21.4%
|
No Preference |
1
7.1%
|
Control |
9
64.3%
|
Title | Subjective Preference for Comfort |
---|---|
Description | Subjective preference for comfort for test and control contact lenses. |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | Subjects were randomized to wear test lens or control contact lenses bilaterally for four days in this cross-over study. |
Measure Participants | 13 |
Test |
4
28.6%
|
No Preference |
3
21.4%
|
Control |
6
42.9%
|
Title | Subjective Overall Lens Preference |
---|---|
Description | Subjective overall lens preference for test and control contact lenses. |
Time Frame | 4 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | Subjects were randomized to wear test lens or control contact lenses bilaterally for four days in this cross-over study. |
Measure Participants | 13 |
Test |
4
28.6%
|
No Preference |
0
0%
|
Control |
9
64.3%
|
Adverse Events
Time Frame | From dispense up to four days on each pair of contact lenses. | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens | ||
Arm/Group Description | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lens | ||
All Cause Mortality |
||||
Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/13 (0%) | 0/13 (0%) | ||
Serious Adverse Events |
||||
Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/13 (0%) | 0/13 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Comfilcon A Extended Range Test Lens | Comfilcon A Control Lens | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/13 (0%) | 0/13 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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 |
---|---|
Organization | CooperVision, Inc. |
Phone | 925-730-6716 |
mnguyen@coopervision.com |
- CV-16-02