Trial Outcomes & Findings for Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens (NCT NCT05765227)

Last Updated: 2024-04-16

Results Overview

VA was assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No hypothesis testing was prespecified for this endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Day 2, each study lens type worn during the corresponding crossover period

Results posted on

2024-04-16

Participant Flow

Participants were recruited from 1 investigative site located in 1 country (US).

Of the 18 enrolled, 1 participant was exited prior to study start as a screen failure. This reporting group includes all participants exposed to any study lenses evaluated in this study (17).

Participant milestones

Participant milestones
Measure	LID#224381, Then AOHG MF Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type was worn bilaterally (in both eyes) for approximately 2 days in a daily wear modality. CLEAR CARE was used for nightly cleaning and disinfection.	AOHG MF, Then LID#224381 Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type was worn bilaterally (in both eyes) for approximately 2 days in a daily wear modality. CLEAR CARE was used for nightly cleaning and disinfection.
First Wear Period (Approx. 2 Days) STARTED	8	9
First Wear Period (Approx. 2 Days) COMPLETED	8	9
First Wear Period (Approx. 2 Days) NOT COMPLETED	0	0
Second Wear Period (Approx. 2 Days) STARTED	8	9
Second Wear Period (Approx. 2 Days) COMPLETED	8	9
Second Wear Period (Approx. 2 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID#224381, Then AOHG MF n=8 Participants Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type was worn bilaterally (in both eyes) for approximately 2 days in a daily wear modality. CLEAR CARE was used for nightly cleaning and disinfection.	AOHG MF, Then LID#224381 n=9 Participants Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type was worn bilaterally (in both eyes) for approximately 2 days in a daily wear modality. CLEAR CARE was used for nightly cleaning and disinfection.	Total n=17 Participants Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 4.3 • n=99 Participants	62.4 years STANDARD_DEVIATION 5.2 • n=107 Participants	63.2 years STANDARD_DEVIATION 4.7 • n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Sex: Female, Male Male	5 Participants n=99 Participants	8 Participants n=107 Participants	13 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=99 Participants	9 Participants n=107 Participants	17 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized White	7 Participants n=99 Participants	7 Participants n=107 Participants	14 Participants n=206 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized Other	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: Day 2, each study lens type worn during the corresponding crossover period

Population: This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.