Trial Outcomes & Findings for A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses (NCT NCT02719366)

NCT ID: NCT02719366

Last Updated: 2020-07-30

Results Overview

Visual acuity for test and control lens was measured at Distance, Intermediate, and Near conditions by LogMAR.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2020-07-30

Participant Flow

Participant milestones

Measure	Test Lens Then Control Lens Subjects will be randomized to wear the test contact lenses first 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 first 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	6	6
First Intervention COMPLETED	6	6
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	6	6
Second Intervention COMPLETED	6	6
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=12 Participants Subjects will be randomized to wear the test contact lenses or control contact lenses bilaterally first for four days then cross-over to alternate study lenses. comfilcon A Extended Range test lens: contact lenses comfilcon A control lens: contact lenses
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants
Age, Continuous	59 years STANDARD_DEVIATION 4 • n=12 Participants
Sex: Female, Male Female	8 Participants n=12 Participants
Sex: Female, Male Male	4 Participants n=12 Participants
Region of Enrollment United States	12 participants n=12 Participants

PRIMARY outcome

Timeframe: 4 days

Visual acuity for test and control lens was measured at Distance, Intermediate, and Near conditions by LogMAR.

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Visual Acuity Distance	-0.07 LogMAR Standard Deviation 0.07	-0.05 LogMAR Standard Deviation 0.09
Visual Acuity Intermediate	0.06 LogMAR Standard Deviation 0.14	0.10 LogMAR Standard Deviation 0.11
Visual Acuity Near	0.09 LogMAR Standard Deviation 0.06	0.05 LogMAR Standard Deviation 0.12

PRIMARY outcome

Timeframe: 4 days

Subjective assessment of visual performance for Distance, Intermediate and Near conditions was collected on a scale of 0-100 (Scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Visual Performance Distance	65 units on a scale Standard Deviation 27	64 units on a scale Standard Deviation 22
Visual Performance Intermediate	77 units on a scale Standard Deviation 16	78 units on a scale Standard Deviation 18
Visual Performance Near	76 units on a scale Standard Deviation 18	65 units on a scale Standard Deviation 24

SECONDARY outcome

Timeframe: Baseline

Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Comfort	92 units on a scale Standard Deviation 8	88 units on a scale Standard Deviation 14

SECONDARY outcome

Timeframe: 4 days

Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Comfort	82 units on a scale Standard Deviation 23	80 units on a scale Standard Deviation 21

SECONDARY outcome

Timeframe: Baseline

Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Dryness	86 units on a scale Standard Deviation 21	87 units on a scale Standard Deviation 18

SECONDARY outcome

Timeframe: 4 days

Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Dryness	84 units on a scale Standard Deviation 17	81 units on a scale Standard Deviation 18

SECONDARY outcome

Timeframe: 4 days

Subjective preference for comfort for test and control contact lenses.

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	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 lenses
Subjective Preference for Comfort Test Lens	4 Participants	—
Subjective Preference for Comfort Control Lens	2 Participants	—
Subjective Preference for Comfort No Preference	6 Participants	—

SECONDARY outcome

Timeframe: 4 days

Subjective satisfaction for test and control lens. Scale 0-100, 0=extremely dissatisfied, 100=very satisfied)

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Subjective Satisfaction	68 units on a scale Standard Deviation 22	75 units on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: 4 days

Subjective preference for Near Vision for test and control contact lenses.

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	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 lenses
Subjective Preference for Near Vision Test Lens	4 Participants	—
Subjective Preference for Near Vision Control Lens	4 Participants	—
Subjective Preference for Near Vision No Preference	4 Participants	—

SECONDARY outcome

Timeframe: 4 days

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

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	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 lenses
Subjective Preference for Intermediate Vision Test Lens	5 Participants	—
Subjective Preference for Intermediate Vision Control Lens	5 Participants	—
Subjective Preference for Intermediate Vision No Preference	2 Participants	—

SECONDARY outcome

Timeframe: 4 days

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

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	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 lenses
Subjective Preference for Distance Vision Test Lens	6 Participants	—
Subjective Preference for Distance Vision Control Lens	4 Participants	—
Subjective Preference for Distance Vision No Preference	2 Participants	—

SECONDARY outcome

Timeframe: 4 days

Subjective overall vision preference for test and control contact lenses.

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	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 lenses
Subjective Overall Vision Preference Test Lens	6 Participants	—
Subjective Overall Vision Preference Control Lens	4 Participants	—
Subjective Overall Vision Preference No Preference	2 Participants	—

SECONDARY outcome

Timeframe: 4 days

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

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Average Daily Wearing Time	11 Hours/Day Standard Deviation 3	11 Hours/Day Standard Deviation 2

SECONDARY outcome

Timeframe: 4 days

Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 scale in 0.25 steps 0- very poor fit.

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Lens Fit	3.7 units on a scale Standard Deviation 0.1	3.8 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 4 Days

Subjective ratings for handling (ease of insertion and removal) was assessed on a Scale of 0-100 (0=very difficult to handle, 100=easy to handle).

Outcome measures

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Lens Handling	90 units on a scale Standard Deviation 13	88 units on a scale Standard Deviation 20

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

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Bulbar Hyperemia	1.27 units on a scale Standard Deviation 0.38	1.09 units on a scale Standard Deviation 0.31

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

Measure	Comfilcon A Extended Range Test Lens n=12 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 lenses	Comfilcon A Control Lens n=12 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 lenses
Limbal Hyperemia	0.93 units on a scale Standard Deviation 0.52	0.76 units on a scale Standard Deviation 0.47

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: mnguyen@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place