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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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

92 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.

Results posted on

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

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

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=5 Participants
32.0 years
STANDARD_DEVIATION 9.6 • n=7 Participants
32.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
33 Participants
n=7 Participants
55 Participants
n=5 Participants
Sex: Female, Male
Male
26 Participants
n=5 Participants
11 Participants
n=7 Participants
37 Participants
n=5 Participants
Race/Ethnicity, Customized
White
35 Participants
n=5 Participants
29 Participants
n=7 Participants
64 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
11 Participants
n=5 Participants
10 Participants
n=7 Participants
21 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 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
Multi-racial
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic or Latino
5 Participants
n=5 Participants
10 Participants
n=7 Participants
15 Participants
n=5 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
43 Participants
n=5 Participants
33 Participants
n=7 Participants
76 Participants
n=5 Participants
Race/Ethnicity, Customized
Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

LID226397 Nonocular

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

AOfAHP Ocular

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

AOfAHP Nonocular

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 1-888-451-3937

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