Trial Outcomes & Findings for The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses (NCT NCT05766787)

Last Updated: 2024-06-13

Results Overview

Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.

Recruitment status

COMPLETED

Study phase

Target enrollment

190 participants

Primary outcome timeframe

Week 1 of each lens product worn during the corresponding crossover period

Results posted on

2024-06-13

Participant Flow

Participants were recruited from 15 investigative sites located in the United States.

Of the 190 enrolled, 3 participants were exited prior to randomization as screen failures. Of the 187 randomized, 1 participant was discontinued prior to exposure to the study lenses due to ocular pre-treatment adverse events. This reporting group includes all participants exposed to any study lenses (186).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	LID022821, Then AOHP Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection.	AOHP, Then LID022821 Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection.
First Wear Period, Approximately 7 Days STARTED	94 188	92 184
First Wear Period, Approximately 7 Days COMPLETED	93 186	89 178
First Wear Period, Approximately 7 Days NOT COMPLETED	1 2	3 6
Second Wear Period, Approximately 7 Days STARTED	93 186	88 176
Second Wear Period, Approximately 7 Days COMPLETED	93 186	87 174
Second Wear Period, Approximately 7 Days NOT COMPLETED	0 0	1 2

Reasons for withdrawal

Reasons for withdrawal
Measure	LID022821, Then AOHP Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection.	AOHP, Then LID022821 Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection.
First Wear Period, Approximately 7 Days Adverse Event	0	1
First Wear Period, Approximately 7 Days Withdrawal by Subject	1	2
Second Wear Period, Approximately 7 Days Adverse Event	0	1

Baseline Characteristics

The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID022821, Then AOHP n=94 Participants Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection.	AOHP, Then LID022821 n=92 Participants Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection.	Total n=186 Participants Total of all reporting groups
Age, Continuous	34.1 years STANDARD_DEVIATION 8.6 • n=5 Participants	33.9 years STANDARD_DEVIATION 9.0 • n=7 Participants	34.0 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	64 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	28 Participants n=7 Participants	62 Participants n=5 Participants
Race/Ethnicity, Customized White	66 Participants n=5 Participants	62 Participants n=7 Participants	128 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	88 Participants n=5 Participants	85 Participants n=7 Participants	173 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 1 of each lens product worn during the corresponding crossover period

Population: Full Analysis Set: All randomized subjects who were exposed to any study lenses evaluated in this study with data at Week 1 visit.