Trial Outcomes & Findings for One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses. (NCT NCT02759471)

Results Overview

Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

baseline, 2 weeks, 1 month

Results posted on

2020-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test) Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). comfilcon A sphere lens (control): contact lens comfilcon A asphere lens (test): contact lens
Overall Study STARTED	54
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test) Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). comfilcon A sphere lens (control): contact lens comfilcon A asphere lens (test): contact lens
Overall Study discomfort	2

Baseline Characteristics

One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test) n=54 Participants Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). comfilcon A sphere lens (control): contact lens comfilcon A asphere lens (test): contact lens
Age, Continuous	26 years n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 2 weeks, 1 month

Population: One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.

Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).

Outcome measures

Outcome measures
Measure	Comfilcon A Sphere (Control) n=52 Participants habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere	Comfilcon A Asphere (Test) n=52 Participants habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
Lens Fit - Centration Baseline, Unacceptable	0 participants	0 participants
Lens Fit - Centration At 2 weeks, optimum	NA participants participants were refitted with test lens and habitual lens were not evaluated at this time point.	45 participants
Lens Fit - Centration At 2 weeks, acceptable	NA participants participants were refitted with test lens and habitual lens were not evaluated at this time point.	6 participants
Lens Fit - Centration At 2 weeks, unacceptable	NA participants participants were refitted with test lens and habitual lens were not evaluated at this time point.	0 participants
Lens Fit - Centration At 1 month, optimum	NA participants participants were refitted with test lens and habitual lens were not evaluated at this time point.	46 participants
Lens Fit - Centration At 1 month, acceptable	NA participants participants were refitted with test lens and habitual lens were not evaluated at this time point.	5 participants
Lens Fit - Centration At 1 month, unacceptable	NA participants participants were refitted with test lens and habitual lens were not evaluated at this time point.	0 participants
Lens Fit - Centration Baseline, Optimum	48 participants	46 participants
Lens Fit - Centration Baseline, Acceptable	4 participants	6 participants

PRIMARY outcome

Timeframe: baseline, 2 weeks, 1 month

Population: One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.

Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).

Outcome measures

Outcome measures
Measure	Comfilcon A Sphere (Control) n=52 Participants habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere	Comfilcon A Asphere (Test) n=52 Participants habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
Lens Fit - Corneal Coverage Baseline, yes	52 participants	52 participants
Lens Fit - Corneal Coverage 2 weeks, yes	51 participants	51 participants
Lens Fit - Corneal Coverage 1 month, yes	51 participants	51 participants

PRIMARY outcome

Timeframe: baseline, 2 weeks, 1 month

Population: One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.

Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

Outcome measures

Outcome measures
Measure	Comfilcon A Sphere (Control) n=52 Participants habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere	Comfilcon A Asphere (Test) n=52 Participants habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
Lens Fit - Post-blink Movement Baseline	1.9 units on a scale Standard Deviation 0.6	1.9 units on a scale Standard Deviation 0.3
Lens Fit - Post-blink Movement After 2 weeks	NA units on a scale Standard Deviation NA participants were refitted with test lens and habitual lens were not evaluated at this time point.	1.9 units on a scale Standard Deviation 0.4
Lens Fit - Post-blink Movement After 1 month	NA units on a scale Standard Deviation NA participants were refitted with test lens and habitual lens were not evaluated at this time point.	1.9 units on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: baseline, 2 weeks, 1 month

Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).

Outcome measures

Outcome measures
Measure	Comfilcon A Sphere (Control) n=52 Participants habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere	Comfilcon A Asphere (Test) habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
Lens Preference/Acceptability Slightly prefer comfilcon A asphere	39 participants	—
Lens Preference/Acceptability Strongly prefer comfilcon A sphere	8 participants	—
Lens Preference/Acceptability Slightly prefer comfilcon A sphere	0 participants	—
Lens Preference/Acceptability Strongly prefer comfilcon A asphere	5 participants	—

Adverse Events

Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)

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

Phone: 1-925-621-3761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and the Sponsor that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication restrictions are in place

Restriction type: OTHER