Trial Outcomes & Findings for A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens (NCT NCT02555098)

Results Overview

Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Baseline (10 minutes post lens settling)

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Sapphire Test Lenses Then Senofilcon A Lenes Each subject was randomized to wear the Investigational lenses (test) for two weeks then cross-over to senofilcon A contact lenses (control) for two weeks. Sapphire contact lenses: Contact Lenses Senofilcon A : Contact lenses	Senofilcon A Then Sapphire Test Lenses Each subject was randomized to wear the senofilcon A contact lenses (control) for two weeks then cross-over to Sapphire lenses (test) for two weeks. Senofilcon A : Contact lenses Sapphire lenses: Contact Lenses
First Intervention STARTED	12	11
First Intervention COMPLETED	12	11
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	12	11
Second Intervention COMPLETED	12	11
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

Baseline characteristics by cohort
Measure	Overall Study n=23 Participants Each subject randomized to wear either the Sapphire lenses (test) or senofilcon A contact lenses (control) as a matched pair for two weeks and cross over to the second matched pair for two weeks.
Age, Categorical <=18 years	0 Participants n=23 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=23 Participants
Age, Categorical >=65 years	0 Participants n=23 Participants
Age, Continuous	40 years STANDARD_DEVIATION 11 • n=23 Participants
Sex: Female, Male Female	20 Participants n=23 Participants
Sex: Female, Male Male	3 Participants n=23 Participants
Region of Enrollment United States	23 participants n=23 Participants

PRIMARY outcome

Timeframe: Baseline (10 minutes post lens settling)

Population: One subject was excluded from the analysis due to compliance.

Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)

Outcome measures

Outcome measures
Measure	Sapphire Lenses n=22 Participants Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire lenses: Contact lenses	Senofilcon A n=22 Participants Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Subjective Ratings for Comfort	89 units on a scale Standard Deviation 14	80 units on a scale Standard Deviation 20

PRIMARY outcome

Timeframe: 2 weeks

Population: One subject was excluded from the analysis due to compliance.

Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)

Outcome measures

Outcome measures
Measure	Sapphire Lenses n=22 Participants Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire lenses: Contact lenses	Senofilcon A n=22 Participants Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Subjective Ratings for Comfort	85 units on a scale Standard Deviation 18	72 units on a scale Standard Deviation 27

PRIMARY outcome

Timeframe: Baseline (10 minutes post lens settling)

Population: One subject was excluded from the analysis due to compliance.

Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference

Outcome measures

Outcome measures
Measure	Sapphire Lenses n=22 Participants Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire lenses: Contact lenses	Senofilcon A Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Subjective Ratings for Comfort Preference Sapphire lens	46 percentage of participants	—
Subjective Ratings for Comfort Preference senofilcon A	18 percentage of participants	—
Subjective Ratings for Comfort Preference No Preference	36 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Population: One subject was excluded from the analysis due to compliance.

Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference

Outcome measures

Outcome measures
Measure	Sapphire Lenses n=22 Participants Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire lenses: Contact lenses	Senofilcon A Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Subjective Ratings for Comfort Preference Sapphire lens	68 percentage of participants	—
Subjective Ratings for Comfort Preference senofilcon A	27 percentage of participants	—
Subjective Ratings for Comfort Preference No Preference	5 percentage of participants	—

PRIMARY outcome

Timeframe: Baseline (10 minutes post lens settling)

Population: One subject was excluded from the analysis due to compliance.

Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)

Outcome measures

Outcome measures
Measure	Sapphire Lenses n=22 Participants Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire lenses: Contact lenses	Senofilcon A n=22 Participants Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Subjective Assessment of Visual Quality	85 units on a scale Standard Deviation 15	85 units on a scale Standard Deviation 21

PRIMARY outcome

Timeframe: 2 weeks

Population: One subject was excluded from the analysis due to compliance.

Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)

Outcome measures

Outcome measures
Measure	Sapphire Lenses n=22 Participants Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire lenses: Contact lenses	Senofilcon A n=22 Participants Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Subjective Assessment of Visual Quality	81 units on a scale Standard Deviation 19	73 units on a scale Standard Deviation 27

PRIMARY outcome

Timeframe: Baseline (10 minutes post lens settling)

Population: One subject was excluded from the analysis due to compliance

Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

Outcome measures

Outcome measures
Measure	Sapphire Lenses n=22 Participants Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire lenses: Contact lenses	Senofilcon A n=22 Participants Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Subjective Assessment of Overall Satisfaction	89 units on a scale Standard Deviation 12	81 units on a scale Standard Deviation 21

PRIMARY outcome

Timeframe: 2 weeks

Population: One subject was excluded from the analysis due to compliance

Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

Outcome measures

Outcome measures
Measure	Sapphire Lenses n=22 Participants Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire lenses: Contact lenses	Senofilcon A n=22 Participants Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Subjective Assessment of Overall Satisfaction	87 units on a scale Standard Deviation 14	73 units on a scale Standard Deviation 30

PRIMARY outcome

Timeframe: Baseline (10 minutes post lens settling)

Population: One subject was excluded from the analysis due to compliance.

Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference

Outcome measures

Outcome measures
Measure	Sapphire Lenses n=22 Participants Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire lenses: Contact lenses	Senofilcon A Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Subjective Overall Preference Sapphire Lens	55 percentage of participants	—
Subjective Overall Preference No Preference	18 percentage of participants	—
Subjective Overall Preference senofilcon A	27 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Population: One subject was excluded from the analysis due to compliance.

Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference

Outcome measures

Outcome measures
Measure	Sapphire Lenses n=22 Participants Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire lenses: Contact lenses	Senofilcon A Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Subjective Overall Preference No Preference	4 percentage of participants	—
Subjective Overall Preference Sapphire Lens	73 percentage of participants	—
Subjective Overall Preference senofilcon A	23 percentage of participants	—

Adverse Events

Sapphire Contact Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon A

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