Trial Outcomes & Findings for Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses. (NCT NCT02727816)

Results Overview

Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Baseline and 1 hour

Results posted on

2018-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Overall Participants Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design.
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Participants n=35 Participants Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design.
Age, Continuous	22.5 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 hour

Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Centration - Pair One Baseline - Optimum	35 number of eyes	35 number of eyes	—
Centration - Pair One Baseline - Decentration acceptable	0 number of eyes	0 number of eyes	—
Centration - Pair One Baseline - Decentration unacceptable	0 number of eyes	0 number of eyes	—
Centration - Pair One 1 hour - Optimum	35 number of eyes	35 number of eyes	—
Centration - Pair One 1 hour - Decentration acceptable	0 number of eyes	0 number of eyes	—
Centration - Pair One 1 hour - Decentration unacceptable	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: Baseline and 1 hour

Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Centration - Pair Two Baseline - Optimum	35 number of eyes	35 number of eyes	—
Centration - Pair Two Baseline - Decentration acceptable	0 number of eyes	0 number of eyes	—
Centration - Pair Two Baseline - Decentration unacceptable	0 number of eyes	0 number of eyes	—
Centration - Pair Two 1 hour - Optimum	35 number of eyes	35 number of eyes	—
Centration - Pair Two 1 hour - Decentration acceptable	0 number of eyes	0 number of eyes	—
Centration - Pair Two 1 hour - Decentration unacceptable	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: Baseline and 1 hour

Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Centration - Pair Three Baseline - Optimum	35 number of eyes	35 number of eyes	—
Centration - Pair Three Baseline - Decentration acceptable	0 number of eyes	0 number of eyes	—
Centration - Pair Three Baseline - Decentration unacceptable	0 number of eyes	0 number of eyes	—
Centration - Pair Three 1 hour - Optimum	35 number of eyes	35 number of eyes	—
Centration - Pair Three 1 hour - Decentration acceptable	0 number of eyes	0 number of eyes	—
Centration - Pair Three 1 hour - Decentration unacceptable	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: Baseline and 1 hour

Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Centration - Pair Four Baseline - Optimum	35 number of eyes	35 number of eyes	—
Centration - Pair Four Baseline - Decentration acceptable	0 number of eyes	0 number of eyes	—
Centration - Pair Four Baseline - Decentration unacceptable	0 number of eyes	0 number of eyes	—
Centration - Pair Four 1 hour - Optimum	35 number of eyes	35 number of eyes	—
Centration - Pair Four 1 hour - Decentration acceptable	0 number of eyes	0 number of eyes	—
Centration - Pair Four 1 hour - Decentration unacceptable	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: Baseline

Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Post-blink Movement - Pair One Insufficient	6 number of eyes	5 number of eyes	—
Post-blink Movement - Pair One Minimum	13 number of eyes	2 number of eyes	—
Post-blink Movement - Pair One Optimum	16 number of eyes	28 number of eyes	—
Post-blink Movement - Pair One Moderate	0 number of eyes	0 number of eyes	—
Post-blink Movement - Pair One Excessive	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: 1 hour

Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Post-blink Movement - Pair One Insufficient	2 number of eyes	0 number of eyes	—
Post-blink Movement - Pair One Minimum	19 number of eyes	9 number of eyes	—
Post-blink Movement - Pair One Optimum	14 number of eyes	26 number of eyes	—
Post-blink Movement - Pair One Moderate	0 number of eyes	0 number of eyes	—
Post-blink Movement - Pair One Excessive	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: Baseline

Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Post-blink Movement - Pair Two Insufficient	3 number of eyes	2 number of eyes	—
Post-blink Movement - Pair Two Minimum	7 number of eyes	16 number of eyes	—
Post-blink Movement - Pair Two Optimum	15 number of eyes	14 number of eyes	—
Post-blink Movement - Pair Two Moderate	10 number of eyes	3 number of eyes	—
Post-blink Movement - Pair Two Excessive	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: 1 hour

Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Post-blink Movement - Pair Two Insufficient	4 number of eyes	1 number of eyes	—
Post-blink Movement - Pair Two Minimum	5 number of eyes	13 number of eyes	—
Post-blink Movement - Pair Two Optimum	23 number of eyes	20 number of eyes	—
Post-blink Movement - Pair Two Moderate	3 number of eyes	1 number of eyes	—
Post-blink Movement - Pair Two Excessive	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: Baseline

Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Post-blink Movement - Pair Three Insufficient	1 number of eyes	0 number of eyes	—
Post-blink Movement - Pair Three Minimum	8 number of eyes	9 number of eyes	—
Post-blink Movement - Pair Three Optimum	26 number of eyes	23 number of eyes	—
Post-blink Movement - Pair Three Moderate	0 number of eyes	3 number of eyes	—
Post-blink Movement - Pair Three Excessive	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: 1 hour

Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Post-blink Movement - Pair Three Insufficient	0 number of eyes	0 number of eyes	—
Post-blink Movement - Pair Three Minimum	10 number of eyes	5 number of eyes	—
Post-blink Movement - Pair Three Optimum	24 number of eyes	28 number of eyes	—
Post-blink Movement - Pair Three Moderate	1 number of eyes	2 number of eyes	—
Post-blink Movement - Pair Three Excessive	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: Baseline

Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Post-blink Movement - Pair Four Insufficient	7 number of eyes	9 number of eyes	—
Post-blink Movement - Pair Four Minimum	7 number of eyes	11 number of eyes	—
Post-blink Movement - Pair Four Optimum	18 number of eyes	14 number of eyes	—
Post-blink Movement - Pair Four Moderate	3 number of eyes	1 number of eyes	—
Post-blink Movement - Pair Four Excessive	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: 1 hour

Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Post-blink Movement - Pair Four Insufficient	3 number of eyes	1 number of eyes	—
Post-blink Movement - Pair Four Minimum	7 number of eyes	10 number of eyes	—
Post-blink Movement - Pair Four Optimum	25 number of eyes	24 number of eyes	—
Post-blink Movement - Pair Four Moderate	0 number of eyes	0 number of eyes	—
Post-blink Movement - Pair Four Excessive	0 number of eyes	0 number of eyes	—

PRIMARY outcome

Timeframe: Baseline and 1 hour

Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Lens Tightness - Pair One Baseline	62.8 Percent lens tightness Standard Deviation 16.2	57.1 Percent lens tightness Standard Deviation 15.8	—
Lens Tightness - Pair One 1 hour	64.9 Percent lens tightness Standard Deviation 15.9	57.1 Percent lens tightness Standard Deviation 14.5	—

PRIMARY outcome

Timeframe: Baseline and 1 hour

Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Lens Tightness - Pair Two Baseline	57.0 percent lens tightness Standard Deviation 17.1	52.3 percent lens tightness Standard Deviation 16.5	—
Lens Tightness - Pair Two 1 hour	57.7 percent lens tightness Standard Deviation 14.8	56.6 percent lens tightness Standard Deviation 17.1	—

PRIMARY outcome

Timeframe: Baseline and 1 hour

Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Lens Tightness - Pair Three Baseline	54.0 percent lens tightness Standard Deviation 7.80	54.3 percent lens tightness Standard Deviation 10.7	—
Lens Tightness - Pair Three 1 hour	54.3 percent lens tightness Standard Deviation 8.50	51.2 percent lens tightness Standard Deviation 6.60	—

PRIMARY outcome

Timeframe: Baseline and 1 hour

Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference
Lens Tightness - Pair Four Baseline	61.1 percent lens tightness Standard Deviation 20.3	66.7 percent lens tightness Standard Deviation 19.9	—
Lens Tightness - Pair Four 1 hour	56.3 percent lens tightness Standard Deviation 12.4	56.6 percent lens tightness Standard Deviation 11.6	—

PRIMARY outcome

Timeframe: Baseline and 1 hour

Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference n=35 Participants
Overall Fit Preference - Pair One Baseline	4 number of subjects	15 number of subjects	16 number of subjects
Overall Fit Preference - Pair One 1 hour	3 number of subjects	17 number of subjects	15 number of subjects

PRIMARY outcome

Timeframe: Baseline and 1 hour

Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference n=35 Participants
Overall Fit Acceptance - Pair Two Baseline	13 number of subjects	9 number of subjects	13 number of subjects
Overall Fit Acceptance - Pair Two 1 hour	13 number of subjects	6 number of subjects	16 number of subjects

PRIMARY outcome

Timeframe: Baseline and 1 hour

Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference n=35 Participants
Overall Fit Acceptance - Pair Three Baseline	12 number of subjects	6 number of subjects	17 number of subjects
Overall Fit Acceptance - Pair Three 1 hour	6 number of subjects	10 number of subjects	19 number of subjects

PRIMARY outcome

Timeframe: Baseline and 1 hour

Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.

Outcome measures

Outcome measures
Measure	Filcon IV I (BC 8.6) - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. filcon IV I (BC 8.6): control lens	Ocufilcon D - Pair One n=35 Participants Participants were randomized to a test and control lens for each pair in a contralateral design. ocufilcon D: test lens	No Preference n=35 Participants
Overall Fit Acceptance - Pair Four Baseline	9 number of subjects	5 number of subjects	21 number of subjects
Overall Fit Acceptance - Pair Four 1 hour	12 number of subjects	8 number of subjects	15 number of subjects

Adverse Events

Overall Participants

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

Senior Manager Global Medical Scientific Affairs

CooperVision Inc.

Phone: 925 621-3761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER