Trial Outcomes & Findings for A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks (NCT NCT02345811)

NCT ID: NCT02345811

Last Updated: 2020-09-16

Results Overview

Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: Baseline (10 minutes post lens settling at dispense)
• Results posted on: 2020-09-16

Participant Flow

Participant milestones

Measure	Sapphire Lens Then Senofilcon A Participants were randomized to wear the Sapphire lens pair for two weeks then cross over to Senofilcon A pair for two weeks. Sapphire Lens: silicone-hydrogel contact lens senofilcon A: contact lens	Senofilcon A Then Sapphire Lens Participants were randomized to wear the senofilcon A lens pair for two weeks then cross over to Sapphire lens pair for two weeks. senofilcon A: contact lens Sapphire lens: silicone-hydrogel contact lens
First Intervention STARTED	17	17
First Intervention COMPLETED	16	16
First Intervention NOT COMPLETED	1	1
Second Intervention STARTED	16	16
Second Intervention COMPLETED	16	16
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Sapphire Lens Then Senofilcon A Participants were randomized to wear the Sapphire lens pair for two weeks then cross over to Senofilcon A pair for two weeks. Sapphire Lens: silicone-hydrogel contact lens senofilcon A: contact lens	Senofilcon A Then Sapphire Lens Participants were randomized to wear the senofilcon A lens pair for two weeks then cross over to Sapphire lens pair for two weeks. senofilcon A: contact lens Sapphire lens: silicone-hydrogel contact lens
First Intervention Withdrawal by Subject	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=32 Participants Subjects were randomized to wear either the test lens or the control lens for 2 weeks and then cross-over to the other lens. Test Lens: Sapphire (contact lens) Control Lens : Senofilcon A (contact lens)
Age, Categorical <=18 years	0 Participants n=32 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=32 Participants
Age, Categorical >=65 years	0 Participants n=32 Participants
Age, Continuous	24 years STANDARD_DEVIATION 9 • n=32 Participants
Sex: Female, Male Female	25 Participants n=32 Participants
Sex: Female, Male Male	7 Participants n=32 Participants
Region of Enrollment Canada	15 participants n=32 Participants
Region of Enrollment United States	17 participants n=32 Participants

PRIMARY outcome

Timeframe: Baseline (10 minutes post lens settling at dispense)

Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=32 Participants Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Vision Quality	93 units on a scale Standard Deviation 9	94 units on a scale Standard Deviation 7

PRIMARY outcome

Timeframe: 2 weeks - During the Day

Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=32 Participants Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Vision Quality	88 units on a scale Standard Deviation 12	91 units on a scale Standard Deviation 11

PRIMARY outcome

Timeframe: 2 weeks - End of Day

Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=32 Participants Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Vision Quality	86 units on a scale Standard Deviation 14	87 units on a scale Standard Deviation 14

PRIMARY outcome

Timeframe: Baseline - 10 minutes post lens settling

Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=32 Participants Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Subjective Rating for Comfort.	91 units on a scale Standard Deviation 12	92 units on a scale Standard Deviation 11

PRIMARY outcome

Timeframe: 2-weeks - During the Day

Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=32 Participants Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Subjective Rating for Comfort.	76 units on a scale Standard Deviation 20	87 units on a scale Standard Deviation 13

PRIMARY outcome

Timeframe: 2-weeks - End of Day

Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=32 Participants Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Subjective Rating for Comfort.	66 units on a scale Standard Deviation 26	81 units on a scale Standard Deviation 17

PRIMARY outcome

Timeframe: Baseline (10 minutes post lens settling)

Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)

Outcome measures

Measure	Sapphire n=64 Eyes Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=64 Eyes Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Lens Surface Wettability	3.2 units on a scale Standard Deviation 0.6	3.2 units on a scale Standard Deviation 0.7

PRIMARY outcome

Timeframe: 2 weeks

Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)

Outcome measures

Measure	Sapphire n=64 Eyes Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=64 Eyes Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Lens Surface Wettability	3.0 units on a scale Standard Deviation 0.8	3.2 units on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline (10 minutes post lens settling)

Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=32 Participants Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Surface Deposits	0.05 units on a scale Standard Deviation 0.18	0.16 units on a scale Standard Deviation 0.40

PRIMARY outcome

Timeframe: 2-weeks

Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=32 Participants Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Surface Deposits	0.45 units on a scale Standard Deviation 0.51	0.40 units on a scale Standard Deviation 0.51

PRIMARY outcome

Timeframe: 2 weeks

Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=32 Participants Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Lens Handling (Ease of Insertion)	93 units on a scale Standard Deviation 10	95 units on a scale Standard Deviation 8

PRIMARY outcome

Timeframe: 2 weeks

Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=32 Participants Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Lens Handling (Ease of Removal)	90 units on a scale Standard Deviation 14	95 units on a scale Standard Deviation 7

PRIMARY outcome

Timeframe: Baseline - 10 minutes post lens settling

Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Subjective Preference for Comfort. Sapphire	22 percentage of participants	—
Subjective Preference for Comfort. senofilcon A	53 percentage of participants	—
Subjective Preference for Comfort. No preference	25 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

Outcome measures

Measure	Sapphire n=32 Participants Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Subjective Preference for Comfort. Sapphire	23 percentage of participants	—
Subjective Preference for Comfort. senofilcon A	68 percentage of participants	—
Subjective Preference for Comfort. No preference	9 percentage of participants	—

Adverse Events

Sapphire

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Senofilcon A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sapphire n=32 participants at risk Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Sapphire: silicone-hydrogel contact lens	Senofilcon A n=32 participants at risk Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. senofilcon A: contact lens
Infections and infestations Sore Throat and Fever	6.2% 2/32 • Number of events 2 • From dispense up to 2 weeks for each study lenses, a total of 4 weeks	0.00% 0/32 • From dispense up to 2 weeks for each study lenses, a total of 4 weeks
Eye disorders Corneal Staining	0.00% 0/32 • From dispense up to 2 weeks for each study lenses, a total of 4 weeks	3.1% 1/32 • Number of events 1 • From dispense up to 2 weeks for each study lenses, a total of 4 weeks
Infections and infestations Pelvic infection	0.00% 0/32 • From dispense up to 2 weeks for each study lenses, a total of 4 weeks	3.1% 1/32 • Number of events 1 • From dispense up to 2 weeks for each study lenses, a total of 4 weeks

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