Trial Outcomes & Findings for Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses (NCT NCT05431478)

Last Updated: 2023-09-21

Results Overview

Visual acuity (VA) was assessed with study lenses in place 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. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

Week 1, each wear period. A wear period was approximately 14 days.

Results posted on

2023-09-21

Participant Flow

Participants were recruited from 5 investigative sites located in the United States.

This reporting group includes all enrolled participants/eyes (68/136).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	LID022821, Then AOHP Serafilcon A contact lenses worn during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. The serafilcon A contact lenses were replaced with a fresh pair at the Week 1 follow-up visit.	AOHP, Then LID022821 Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2. Each study lens type was worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. The serafilcon A contact lenses were replaced with a fresh pair at the Week 1 follow-up visit.
Period 1, Approximately 14 Days STARTED	34 68	34 68
Period 1, Approximately 14 Days COMPLETED	34 68	34 68
Period 1, Approximately 14 Days NOT COMPLETED	0 0	0 0
Period 2, Approximately 14 Days STARTED	34 68	34 68
Period 2, Approximately 14 Days COMPLETED	34 68	34 68
Period 2, Approximately 14 Days NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID022821, Then AOHP n=34 Participants Serafilcon A contact lenses worn during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. The serafilcon A contact lenses were replaced with a fresh pair at the Week 1 follow-up visit.	AOHP, Then LID022821 n=34 Participants Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. The serafilcon A contact lenses were replaced with a fresh pair at the Week 1 follow-up visit.	Total n=68 Participants Total of all reporting groups
Age, Continuous	33.6 years STANDARD_DEVIATION 7.1 • n=5 Participants	30.9 years STANDARD_DEVIATION 6.5 • n=7 Participants	32.3 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	33 Participants n=7 Participants	65 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	34 Participants n=7 Participants	68 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	34 participants n=5 Participants	34 participants n=7 Participants	68 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 1, each wear period. A wear period was approximately 14 days.

Population: Safety Analysis Set.