Trial Outcomes & Findings for Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens (NCT NCT04631796)

Last Updated: 2022-01-12

Results Overview

Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Dispense; Week 2 Follow-up

Results posted on

2022-01-12

Participant Flow

Subjects were recruited from 3 investigative sites located in the United States.

Of the 36 enrolled, 1 subject was exited from the study prior to product exposure as a screen failure. This reporting group includes all subjects/eyes exposed to any study lenses evaluated in this study, except for the lenses used with the purpose of power optimization (Safety Analysis Set).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	LID020098 Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses were removed nightly for cleaning and disinfection.
Overall Study STARTED	35 70
Overall Study COMPLETED	35 70
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID020098 n=35 Participants Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses were removed nightly for cleaning and disinfection.
Age, Continuous	34.4 years STANDARD_DEVIATION 9.0 • n=93 Participants
Sex: Female, Male Female	21 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	34 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	35 participants n=93 Participants

PRIMARY outcome

Timeframe: Dispense; Week 2 Follow-up

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	LID020098 n=70 eyes Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses were removed nightly for cleaning and disinfection.
Front Surface Wettability, by Category Dispense, Grade 0	70 eyes
Front Surface Wettability, by Category Dispense, Grade 1	0 eyes
Front Surface Wettability, by Category Dispense, Grade 2	0 eyes
Front Surface Wettability, by Category Dispense, Grade 3	0 eyes
Front Surface Wettability, by Category Dispense, Grade 4	0 eyes
Front Surface Wettability, by Category Week 2 Follow-up, Grade 0	70 eyes
Front Surface Wettability, by Category Week 2 Follow-up, Grade 1	0 eyes
Front Surface Wettability, by Category Week 2 Follow-up, Grade 2	0 eyes
Front Surface Wettability, by Category Week 2 Follow-up, Grade 3	0 eyes
Front Surface Wettability, by Category Week 2 Follow-up, Grade 4	0 eyes

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LID020098 Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LID020098 Nonocular

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pretreatment n=35 participants at risk Events reported in this group occurred prior to exposure to the study contact lenses	LID020098 Ocular n=70 participants at risk Events reported in this group occurred while exposed to the study contact lenses	LID020098 Nonocular n=35 participants at risk Events reported in this group occurred while exposed to the study contact lenses
Infections and infestations COVID-19	0.00% 0/35 • Adverse events (AE's) were collected from time of consent to study exit, approximately 2 weeks. 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. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study, except for the lenses used with the purpose of power optimization.	0.00% 0/70 • Adverse events (AE's) were collected from time of consent to study exit, approximately 2 weeks. 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. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study, except for the lenses used with the purpose of power optimization.	5.7% 2/35 • Adverse events (AE's) were collected from time of consent to study exit, approximately 2 weeks. 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. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study, except for the lenses used with the purpose of power optimization.

Additional Information

CDMA 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