Trial Outcomes & Findings for A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses (NCT NCT02719353)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

4 days

Results posted on

2020-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Test Lens Then Control Lens 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	Control Lens Then Test Lens 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
First Intervention STARTED	7	7
First Intervention COMPLETED	7	6
First Intervention NOT COMPLETED	0	1
Second Intervention STARTED	7	6
Second Intervention COMPLETED	7	6
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Lens Then Control Lens 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	Control Lens Then Test Lens 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
First Intervention Physician Decision	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=14 Participants 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
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=14 Participants
Age, Categorical >=65 years	0 Participants n=14 Participants
Age, Continuous	57 years STANDARD_DEVIATION 7 • n=14 Participants
Sex: Female, Male Female	13 Participants n=14 Participants
Sex: Female, Male Male	1 Participants n=14 Participants
Region of Enrollment United States	14 participants n=14 Participants

PRIMARY outcome

Timeframe: 4 days

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

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Visual Acuity Distance	-0.01 LogMAR Standard Deviation 0.09	-0.07 LogMAR Standard Deviation 0.10
Visual Acuity Intermediate	-0.15 LogMAR Standard Deviation 0.16	-0.13 LogMAR Standard Deviation 0.10
Visual Acuity Near	-0.02 LogMAR Standard Deviation 0.09	0.01 LogMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Visual Performance Distance	72 units on a scale Standard Deviation 19	77 units on a scale Standard Deviation 20
Visual Performance Intermediate	85 units on a scale Standard Deviation 17	88 units on a scale Standard Deviation 13
Visual Performance Near	79 units on a scale Standard Deviation 23	80 units on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Subjective Ratings for Comfort	96 units on a scale Standard Deviation 8	91 units on a scale Standard Deviation 6

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Subjective Ratings for Comfort	87 units on a scale Standard Deviation 21	89 units on a scale Standard Deviation 17

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Subjective Ratings for Dryness	94 units on a scale Standard Deviation 9	94 units on a scale Standard Deviation 7

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Subjective Ratings for Dryness	83 units on a scale Standard Deviation 23	88 units on a scale Standard Deviation 14

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Lens Handling	89 units on a scale Standard Deviation 25	95 units on a scale Standard Deviation 9

SECONDARY outcome

Timeframe: 4 days

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

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Average Daily Wearing Time	10 Hours/day Standard Deviation 2	9 Hours/day Standard Deviation 3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Lens Fit	3.3 units on a scale Standard Deviation 0.4	3.3 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Bulbar Hyperemia	0.88 units on a scale Standard Deviation 0.44	0.89 units on a scale Standard Deviation 0.42

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Limbal Hyperemia	0.13 units on a scale Standard Deviation 0.26	0.18 units on a scale Standard Deviation 0.28

SECONDARY outcome

Timeframe: 4 days

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

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control Lens n=13 Participants 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
Subjective Satisfaction	71 units on a scale Standard Deviation 23	74 units on a scale Standard Deviation 19

SECONDARY outcome

Timeframe: 4 days

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

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control 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
Subjective Preference for Near Vision Test	4 Participants	—
Subjective Preference for Near Vision No Preference	4 Participants	—
Subjective Preference for Near Vision Control	5 Participants	—

SECONDARY outcome

Timeframe: 4 days

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

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control 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
Subjective Preference for Distance Vision Test	3 Participants	—
Subjective Preference for Distance Vision No Preference	2 Participants	—
Subjective Preference for Distance Vision Control	8 Participants	—

SECONDARY outcome

Timeframe: 4 days

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

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control 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
Subjective Preference for Intermediate Vision Test	3 Participants	—
Subjective Preference for Intermediate Vision No Preference	4 Participants	—
Subjective Preference for Intermediate Vision Control	6 Participants	—

SECONDARY outcome

Timeframe: 4 days

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

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control 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
Subjective Preference for Overall Vision Test	3 Participants	—
Subjective Preference for Overall Vision No Preference	1 Participants	—
Subjective Preference for Overall Vision Control	9 Participants	—

SECONDARY outcome

Timeframe: 4 days

Subjective preference for comfort for test and control contact lenses.

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control 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
Subjective Preference for Comfort Test	4 Participants	—
Subjective Preference for Comfort No Preference	3 Participants	—
Subjective Preference for Comfort Control	6 Participants	—

SECONDARY outcome

Timeframe: 4 days

Subjective overall lens preference for test and control contact lenses.

Outcome measures

Outcome measures
Measure	Comfilcon A Extended Range Test Lens n=13 Participants 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	Comfilcon A Control 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
Subjective Overall Lens Preference Test	4 Participants	—
Subjective Overall Lens Preference No Preference	0 Participants	—
Subjective Overall Lens Preference Control	9 Participants	—

Adverse Events

Comfilcon A Extended Range Test Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon A Control Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Myhanh Nguyen

CooperVision, Inc.

Phone: 925-730-6716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place