A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02719353
Collaborator
(none)
14
1
2
5
2.8

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
  • Device: comfilcon A Extended Range test lens
  • Device: comfilcon A control lens
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

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
Aug 1, 2016

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

  1. Visual Acuity [4 days]

    Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR.

  2. 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

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. Average Daily Wearing Time [4 days]

    Average daily wearing time for test and control lens is assessed in hours.

  7. 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.

  8. 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.

  9. 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.

  10. Subjective Satisfaction [4 days]

    Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied)

  11. Subjective Preference for Near Vision [4 days]

    Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction.

  12. Subjective Preference for Distance Vision [4 days]

    Subjective preference for distance vision for test and control contact lenses.

  13. Subjective Preference for Intermediate Vision [4 days]

    Subjective preference for intermediate vision for test and control contact lenses.

  14. Subjective Preference for Overall Vision [4 days]

    Subjective preference for overall vision for test and control contact lenses.

  15. Subjective Preference for Comfort [4 days]

    Subjective preference for comfort for test and control contact lenses.

  16. Subjective Overall Lens Preference [4 days]

    Subjective overall lens preference for test and control contact lenses.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT02719353
Other Study ID Numbers:
  • CV-16-02
First Posted:
Mar 25, 2016
Last Update Posted:
Jul 30, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Primary Outcome
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)
3. Secondary Outcome
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)
4. Secondary Outcome
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)
5. Secondary Outcome
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)
6. Secondary Outcome
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)
7. Secondary Outcome
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)
8. Secondary Outcome
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)
9. Secondary Outcome
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)
10. Secondary Outcome
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)
11. Secondary Outcome
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)
12. Secondary Outcome
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)
13. Secondary Outcome
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%
14. Secondary Outcome
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%
15. Secondary Outcome
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%
16. Secondary Outcome
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%
17. Secondary Outcome
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%
18. Secondary Outcome
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

[Not Specified]

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
Email mnguyen@coopervision.com
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT02719353
Other Study ID Numbers:
  • CV-16-02
First Posted:
Mar 25, 2016
Last Update Posted:
Jul 30, 2020
Last Verified:
Jul 1, 2020