Trial Outcomes & Findings for Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses (NCT NCT04908488)

Last Updated: 2022-10-18

Results Overview

Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Recruitment status

COMPLETED

Study phase

Target enrollment

115 participants

Primary outcome timeframe

Day 8 (-0/+3 days), each study lens type

Results posted on

2022-10-18

Participant Flow

Study participants were recruited from 8 investigative sites located in the United States.

Of the 115 enrolled, 1 participant was exited from the study prior to randomization as a screen failure. This reporting group includes all subjects/eyes exposed to any study lenses evaluated in this study (114).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	P1fA, Then AMfA Verofilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.	AMfA, Then P1fA Etafilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
First Wear Period (8 -0/+3 Days) STARTED	56 112	58 116
First Wear Period (8 -0/+3 Days) COMPLETED	55 110	58 116
First Wear Period (8 -0/+3 Days) NOT COMPLETED	1 2	0 0
Second Wear Period (8 -0/+3 Days) STARTED	55 110	58 116
Second Wear Period (8 -0/+3 Days) COMPLETED	54 108	58 116
Second Wear Period (8 -0/+3 Days) NOT COMPLETED	1 2	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	P1fA, Then AMfA Verofilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.	AMfA, Then P1fA Etafilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
First Wear Period (8 -0/+3 Days) Adverse Event	1	0
Second Wear Period (8 -0/+3 Days) Withdrawal by Subject	1	0

Baseline Characteristics

Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	P1fA, Then AMfA n=56 Participants Verofilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.	AMfA, Then P1fA n=58 Participants Etafilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.	Total n=114 Participants Total of all reporting groups
Age, Continuous	32.5 years STANDARD_DEVIATION 9.9 • n=5 Participants	32.1 years STANDARD_DEVIATION 10.3 • n=7 Participants	32.3 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	39 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	19 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	47 Participants n=7 Participants	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	36 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	56 participants n=5 Participants	58 participants n=7 Participants	114 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8 (-0/+3 days), each study lens type

Population: Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study with non-missing response

Outcome measures

Outcome measures
Measure	P1fA n=224 eyes Verofilcon A toric contact lenses worn bilaterally (in both eyes) during the first wear period or the second wear period, as randomized, for 8 -0/+3 days in a daily disposable modality	AMfA n=220 eyes Etafilcon A toric contact lenses worn bilaterally (in both eyes) during the first wear period or the second wear period, as randomized, for 8 -0/+3 days in a daily disposable modality
Least Squares Mean Distance VA (logMAR) With Study Lenses	-0.08 logMAR Standard Error 0.006	-0.07 logMAR Standard Error 0.006

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

P1fA Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

P1fA Nonocular

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

AMfA Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AMfA Nonocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=114 participants at risk Events reported in this group occurred prior to exposure to the study contact lenses	P1fA Ocular n=228 participants at risk Events reported in this group occurred while exposed to the verofilcon A toric contact lenses	P1fA Nonocular n=114 participants at risk Events reported in this group occurred while exposed to the verofilcon A toric contact lenses	AMfA Ocular n=226 participants at risk Events reported in this group occurred while exposed to the etafilcon A toric contact lenses	AMfA Nonocular n=113 participants at risk Events reported in this group occurred while exposed to the etafilcon A toric contact lenses
Cardiac disorders Atrial fibrillation	0.00% 0/114 • Adverse events (AE's) were collected from time of consent to study exit, approximately 22 days. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. The safety analysis set includes all subjects/eyes exposed to any study lenses evaluated in this study.	0.00% 0/228 • Adverse events (AE's) were collected from time of consent to study exit, approximately 22 days. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. The safety analysis set includes all subjects/eyes exposed to any study lenses evaluated in this study.	0.88% 1/114 • Adverse events (AE's) were collected from time of consent to study exit, approximately 22 days. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. The safety analysis set includes all subjects/eyes exposed to any study lenses evaluated in this study.	0.00% 0/226 • Adverse events (AE's) were collected from time of consent to study exit, approximately 22 days. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. The safety analysis set includes all subjects/eyes exposed to any study lenses evaluated in this study.	0.00% 0/113 • Adverse events (AE's) were collected from time of consent to study exit, approximately 22 days. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. The safety analysis set includes all subjects/eyes exposed to any study lenses evaluated in this study.

Other adverse events

Adverse event data not reported

Additional Information

Sr. Project Lead, Vision Care

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER