Trial Outcomes & Findings for Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear (NCT NCT03418064)

NCT ID: NCT03418064

Last Updated: 2019-11-13

Results Overview

Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2019-11-13

Participant Flow

Participant milestones

Measure	Fanfilcon A Toric, Then Lotrafilcon B Toric Subjects wore fanfilcon A toric contact lens for 1 month, then lotrafilcon B toric contact lens. Fanfilcon A toric: contact lens Lotrafilcon B toric: contact lens	Lotrafilcon B Toric, Then Fanfilcon A Toric Subjects wore lotrafilcon B toric contact lens for 1 month, then fanfilcon A toric contact lens. Lotrafilcon B toric: Contact lens Fanfilcon A toric: contact lens
First Intervention (1 Month) STARTED	21	21
First Intervention (1 Month) COMPLETED	21	21
First Intervention (1 Month) NOT COMPLETED	0	0
Second Intervention (1 Month) STARTED	21	21
Second Intervention (1 Month) COMPLETED	21	21
Second Intervention (1 Month) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear

Baseline characteristics by cohort

Measure	Fanfilcon A Toric vs. Lotrafilcon B Toric Contact Lens n=42 Participants Each subject is randomized to wear either the fanfilcon A toric or lotrafilcon B toric contact lens as a matched pair and crossed over to second matched pair.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	27.7 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	42 Participants n=5 Participants
Region of Enrollment Mexico	42 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Lens Centration 1-Optimal Centration	41 Participants	—
Lens Centration 2-Decentration acceptable	1 Participants	—
Lens Centration 3-Decentranation Unacceptable	0 Participants	—

PRIMARY outcome

Timeframe: Dispense

Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense n=42 Participants Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Lens Centration 1-Optimal Centration	42 Participants	42 Participants
Lens Centration 2-Decentration acceptable	0 Participants	0 Participants
Lens Centration 3-Decentranation Unacceptable	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 Month

Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense n=42 Participants Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Lens Centration 1-Optimal Centration	42 Participants	42 Participants
Lens Centration 2-Decentration acceptable	0 Participants	0 Participants
Lens Centration 3-Decentranation Unacceptable	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline

Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Corneal Coverage Full Coverage (Yes)	42 Participants	—
Corneal Coverage Incomplete (No)	0 Participants	—

PRIMARY outcome

Timeframe: Dispense

Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense n=42 Participants Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Corneal Coverage Full Coverage (Yes)	42 Participants	42 Participants
Corneal Coverage Incomplete (No)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 Month

Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense n=42 Participants Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Corneal Coverage Full Coverage (Yes)	42 Participants	42 Participants
Corneal Coverage Incomplete (No)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline

Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Post-blink Movement	2.17 score on a scale Standard Deviation 0.5	—

PRIMARY outcome

Timeframe: Dispense

Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense n=42 Participants Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Post-blink Movement	2.02 score on a scale Standard Deviation 0.2	2.05 score on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: 1 Month

Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense n=42 Participants Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Post-blink Movement	2.00 score on a scale Standard Deviation 0.0	2.10 score on a scale Standard Deviation 0.4

PRIMARY outcome

Timeframe: Dispense

Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense n=42 Participants Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Overall Fit Acceptance	3.8 units on a scale Standard Deviation 0.5	2.4 units on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: 1 Month

Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense n=42 Participants Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Overall Fit Acceptance	3.9 units on a scale Standard Deviation 0.4	2.5 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline

Number of hours lenses are worn per day

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Average Hours of Wear Per Day	13.8 hours per day Standard Deviation 3.0	—

SECONDARY outcome

Timeframe: 1 month

Number of hours lenses are worn per day

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense n=42 Participants Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Average Hours of Wear Per Day	14.1 hours per day Standard Deviation 2.9	14.0 hours per day Standard Deviation 2.6

SECONDARY outcome

Timeframe: Baseline

Typical time of day when subject first experiences lens awareness or irritation.

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Average Comfortable Wearing Time	11.5 hours per day Standard Deviation 2.9	—

SECONDARY outcome

Timeframe: 1 Month

Typical time of day when subject first experiences lens awareness or irritation

Outcome measures

Measure	Habitual Toric Lens at Baseline n=42 Participants Subjects were evaluated at baseline with their habitual toric lenses.	Lotrafilcon B Toric at Dispense n=42 Participants Subjects who wore lotrafilcon B toric contact lens for 1 month, either randomized as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens
Average Comfortable Wearing Time	11.4 hours per day Standard Deviation 3.3	11.0 hours per day Standard Deviation 3.4

Adverse Events

Fanfilcon A Toric

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lotrafilcon B Toric

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, O.D., MSc., FAAO

CooperVision

Phone: 19256213761

Email: jvega2@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator cannot publish / present data without prior consent from CooperVision.
• Publication restrictions are in place

Restriction type: OTHER