Trial Outcomes & Findings for Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses (NCT NCT05338333)

Last Updated: 2023-09-13

Results Overview

Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together 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

101 participants

Primary outcome timeframe

Day 30, each wear period. A wear period was approximately 30 days.

Results posted on

2023-09-13

Participant Flow

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

This reporting group includes all enrolled participants, as treated (101). Note, one subject that was randomized to AOHG MF, then LID210464 was exposed to LID210464, then AOHG MF instead.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	LID210464, Then AOHG MF Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for daily contact lens cleaning and disinfecting.	AOHG MF, Then LID210464 Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting.
Period 1, Approximately 30 Days STARTED	51 102	50 100
Period 1, Approximately 30 Days COMPLETED	50 100	50 100
Period 1, Approximately 30 Days NOT COMPLETED	1 2	0 0
Period 2, Approximately 30 Days STARTED	50 100	50 100
Period 2, Approximately 30 Days COMPLETED	50 100	50 100
Period 2, Approximately 30 Days NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	LID210464, Then AOHG MF Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for daily contact lens cleaning and disinfecting.	AOHG MF, Then LID210464 Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting.
Period 1, Approximately 30 Days Adverse Event	1	0

Baseline Characteristics

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID210464, Then AOHG MF n=51 Participants Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for daily contact lens cleaning and disinfecting.	AOHG MF, Then LID210464 n=50 Participants Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting.	Total n=101 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 6.9 • n=5 Participants	50.0 years STANDARD_DEVIATION 6.1 • n=7 Participants	50.8 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	38 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	51 participants n=5 Participants	50 participants n=7 Participants	101 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30, each wear period. A wear period was approximately 30 days.

Population: Full Analysis Set: All randomized subjects/eyes exposed to any study lenses evaluated in this study.

Outcome measures

Outcome measures
Measure	LID210464 n=100 eyes Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1 or Period 2, as randomized, in both eyes for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting.	AOHG MF n=100 eyes Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1 or Period 2, as randomized, in both eyes for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting.
Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses	-0.10 logMAR Standard Error 0.010	-0.09 logMAR Standard Error 0.010

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LID210464 Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LID210464 Non-Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AOHG MF Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AOHG MF Non-Ocular

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=101 participants at risk Events reported in this group occurred prior to exposure to the study contact lenses	LID210464 Ocular n=202 participants at risk Events reported in this group occurred while exposed to the lehfilcon A contact lenses	LID210464 Non-Ocular n=101 participants at risk Events reported in this group occurred while exposed to the lehfilcon A contact lenses	AOHG MF Ocular n=200 participants at risk Events reported in this group occurred while exposed to the lotrafilcon B contact lenses	AOHG MF Non-Ocular n=100 participants at risk Events reported in this group occurred while exposed to the lotrafilcon B contact lenses
Investigations Blood potassium decreased	0.00% 0/101 • Adverse events (AE's) were collected from time of consent to study exit, approximately 60 days. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AE's is reported in units of eyes according to actual study lens exposure. All other populations are reported in units of subjects.	0.00% 0/202 • Adverse events (AE's) were collected from time of consent to study exit, approximately 60 days. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AE's is reported in units of eyes according to actual study lens exposure. All other populations are reported in units of subjects.	0.00% 0/101 • Adverse events (AE's) were collected from time of consent to study exit, approximately 60 days. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AE's is reported in units of eyes according to actual study lens exposure. All other populations are reported in units of subjects.	0.00% 0/200 • Adverse events (AE's) were collected from time of consent to study exit, approximately 60 days. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AE's is reported in units of eyes according to actual study lens exposure. All other populations are reported in units of subjects.	1.0% 1/100 • Adverse events (AE's) were collected from time of consent to study exit, approximately 60 days. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AE's is reported in units of eyes according to actual study lens exposure. All other populations are reported in units of subjects.

Other adverse events

Adverse event data not reported

Additional Information

Sr. Clinical 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