Trial Outcomes & Findings for A Clinical Comparison of 2 Multifocal Toric XR (Extended Range) Contact Lenses (NCT NCT03006458)

NCT ID: NCT03006458

Last Updated: 2020-06-01

Results Overview

Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2020-06-01

Participant Flow

Participant milestones

Measure	Comfilcon A Then Omafilcon B Participants were randomized to wear comfilcon A for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B Then Comfilcon A Participants were randomized to wear omafilcon B for two weeks during the cross over study. omafilcon B: toric contact lens
First Intervention STARTED	14	10
First Intervention COMPLETED	14	7
First Intervention NOT COMPLETED	0	3
Second Intervention STARTED	14	10
Second Intervention COMPLETED	14	10
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Comfilcon A Then Omafilcon B Participants were randomized to wear comfilcon A for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B Then Comfilcon A Participants were randomized to wear omafilcon B for two weeks during the cross over study. omafilcon B: toric contact lens
First Intervention Unsatisfied Vision	0	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=24 Participants Total Participants
Age, Categorical <=18 years	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=24 Participants
Age, Continuous	56.2 years STANDARD_DEVIATION 6.2 • n=24 Participants
Sex: Female, Male Female	11 Participants n=24 Participants
Sex: Female, Male Male	13 Participants n=24 Participants
Region of Enrollment United Kingdom	24 participants n=24 Participants

PRIMARY outcome

Timeframe: Baseline

Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Stability	3.2 units on a scale Standard Deviation 1.5	2.9 units on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: 2 weeks

Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Stability	3.2 units on a scale Standard Deviation 0.7	2.5 units on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: Baseline

Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Overall Toric Lens Fit Acceptance	3.3 units on a scale Standard Deviation 0.5	3.2 units on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: 2 weeks

Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Overall Toric Lens Fit Acceptance	3.5 units on a scale Standard Deviation 0.6	2.8 units on a scale Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Comfort	81.6 units on a scale Standard Deviation 20.3	79.7 units on a scale Standard Deviation 21.6

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Comfort	79.8 units on a scale Standard Deviation 21.8	70.6 units on a scale Standard Deviation 27.2

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Overall Satisfaction	63.0 units on a scale Standard Deviation 31.4	63.3 units on a scale Standard Deviation 34.4

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Dryness	80.4 units on a scale Standard Deviation 24.7	77.2 units on a scale Standard Deviation 24.1

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Visual Fluctuation/ Stability	81.0 units on a scale Standard Deviation 16.1	73.8 units on a scale Standard Deviation 25.5

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Handling	84.5 units on a scale Standard Deviation 15.0	85.8 units on a scale Standard Deviation 17.1

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Quality of Near Vision	38.5 units on a scale Standard Deviation 30.5	56.4 units on a scale Standard Deviation 28.9

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Quality of Intermediate Vision	50.2 units on a scale Standard Deviation 29.5	65.3 units on a scale Standard Deviation 25.6

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Quality of Distance Vision	86.2 units on a scale Standard Deviation 13.7	67.3 units on a scale Standard Deviation 25.5

PRIMARY outcome

Timeframe: 2 weeks

Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

Outcome measures

Measure	Comfilcon A n=20 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=17 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Quality of Vision While Driving During the Day	87.3 units on a scale Standard Deviation 14.6	76.2 units on a scale Standard Deviation 25.4

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

Outcome measures

Measure	Comfilcon A n=20 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=15 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Quality of Vision While Driving During the Night	78.0 units on a scale Standard Deviation 18.6	67.0 units on a scale Standard Deviation 23.4

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.

Outcome measures

Measure	Comfilcon A n=23 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Ghosting at Near	66.5 units on a scale Standard Deviation 35.0	78.1 units on a scale Standard Deviation 27.0

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.

Outcome measures

Measure	Comfilcon A n=24 Participants Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Omafilcon B n=21 Participants Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Ghosting at Distance	83.3 units on a scale Standard Deviation 24.8	86.9 units on a scale Standard Deviation 24.4

Adverse Events

Comfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omafilcon B

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

Phone: 9257306716

Email: MNguyen@coopervision.com

Results disclosure agreements

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