Trial Outcomes & Findings for Performance of Wearers of Stenfilcon A Contact Lenses After A Refit With Test Lenses (NCT NCT03496701)

NCT ID: NCT03496701

Last Updated: 2021-06-30

Results Overview

Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 77 participants
• Primary outcome timeframe: Baseline (After 10 minutes of lens dispense)
• Results posted on: 2021-06-30

Participant Flow

Participant milestones

Measure	Overall Study All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week. Test lens: contact lens control lens: contact lens
Overall Study STARTED	77
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	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=77 Participants All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week. Test lens: contact lens control lens: contact lens
Age, Categorical <=18 years	0 Participants n=77 Participants
Age, Categorical Between 18 and 65 years	77 Participants n=77 Participants
Age, Categorical >=65 years	0 Participants n=77 Participants
Age, Continuous	27.9 years STANDARD_DEVIATION 5.1 • n=77 Participants
Sex: Female, Male Female	57 Participants n=77 Participants
Sex: Female, Male Male	20 Participants n=77 Participants
Region of Enrollment United States	77 participants n=77 Participants

PRIMARY outcome

Timeframe: Baseline (After 10 minutes of lens dispense)

Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)

Outcome measures

Measure	Stenfilcon A Test Lens n=77 Participants All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	Stenfilcon A Control Lens n=77 Participants All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Overall Lens Fit Acceptance	3.90 units on a scale Standard Deviation 0.26	3.81 units on a scale Standard Deviation 0.34

PRIMARY outcome

Timeframe: 1 week on each study lenses

Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)

Outcome measures

Measure	Stenfilcon A Test Lens n=77 Participants All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	Stenfilcon A Control Lens n=77 Participants All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Overall Lens Fit Acceptance	3.79 units on a scale Standard Deviation 0.47	3.83 units on a scale Standard Deviation 0.35

SECONDARY outcome

Timeframe: Baseline - After 10 minutes of lens dispense

Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)

Outcome measures

Measure	Stenfilcon A Test Lens n=77 Participants All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	Stenfilcon A Control Lens n=77 Participants All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Lens Centration Optimum	76 Participants	76 Participants
Lens Centration Acceptable	1 Participants	1 Participants
Lens Centration Unacceptable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 week on each study lenses

Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)

Outcome measures

Measure	Stenfilcon A Test Lens n=77 Participants All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	Stenfilcon A Control Lens n=77 Participants All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Lens Centration Optimum	75 Participants	76 Participants
Lens Centration Acceptable	2 Participants	1 Participants
Lens Centration Unacceptable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (after 10 minutes of lens dispense)

Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)

Outcome measures

Measure	Stenfilcon A Test Lens n=77 Participants All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	Stenfilcon A Control Lens n=77 Participants All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Post-blink Movement	2.04 units on a scale Standard Deviation 0.34	1.97 units on a scale Standard Deviation 0.36

SECONDARY outcome

Timeframe: 1 week on each study lenses

Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)

Outcome measures

Measure	Stenfilcon A Test Lens n=77 Participants All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	Stenfilcon A Control Lens n=77 Participants All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Post-blink Movement	1.92 units on a scale Standard Deviation 0.42	1.96 units on a scale Standard Deviation 0.34

Adverse Events

Stenfilcon A Test Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stenfilcon 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

Jose A. Vega

CooperVision, Inc

Phone: 925-640-2964

Email: javega2@coopervision.com

Results disclosure agreements

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