Trial Outcomes & Findings for Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses (NCT NCT05959200)
NCT ID: NCT05959200
Last Updated: 2024-11-29
Results Overview
The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal \[+\] or temporal \[-\]). No hypothesis testing was prespecified for this endpoint.
COMPLETED
NA
92 participants
Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment.
2024-11-29
Participant Flow
Participants were recruited from 7 investigative sites located in 1 country (US).
This reporting group includes all participants exposed to any study lenses evaluated in this study.
Unit of analysis: eyes
Participant milestones
| Measure |
LID226397, Then AOfAHP
Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product was worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
|
AOfAHP, Then LID226397
Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product was worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
|
|---|---|---|
|
First Wear Period (Approx. 14 Days)
STARTED
|
48 96
|
44 88
|
|
First Wear Period (Approx. 14 Days)
COMPLETED
|
48 96
|
44 88
|
|
First Wear Period (Approx. 14 Days)
NOT COMPLETED
|
0 0
|
0 0
|
|
Second Wear Period (Approx. 14 Days)
STARTED
|
48 96
|
44 88
|
|
Second Wear Period (Approx. 14 Days)
COMPLETED
|
48 96
|
44 88
|
|
Second Wear Period (Approx. 14 Days)
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses
Baseline characteristics by cohort
| Measure |
LID226397, Then AOfAHP
n=48 Participants
Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product was worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
|
AOfAHP, Then LID226397
n=44 Participants
Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product was worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.7 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
32.0 years
STANDARD_DEVIATION 9.6 • n=107 Participants
|
32.3 years
STANDARD_DEVIATION 9.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 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
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 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
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment.Population: Full Analysis Set: All randomized subjects/eyes exposed to any study lenses evaluated in this study.
The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal \[+\] or temporal \[-\]). No hypothesis testing was prespecified for this endpoint.
Outcome measures
| Measure |
LID226397
n=184 eyes
Serafilcon A toric contact lenses worn during Period 1 or Period 2, as pre-determined.
|
AOfAHP
n=184 eyes
Senofilcon A toric contact lenses worn during Period 1 or Period 2, as pre-determined.
|
|---|---|---|
|
Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion
|
100.0 percentage of lenses
|
100.0 percentage of lenses
|
Adverse Events
LID226397 Ocular
LID226397 Nonocular
AOfAHP Ocular
AOfAHP Nonocular
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr. Clinical Project Lead, Vision Care
Alcon Research, LLC
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