CompletedNCT05959200Updated Nov 29, 2024Results posted

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses

An interventional study of Serafilcon A toric contact lenses and Senofilcon A toric contact lenses in Ametropia, Myopia and Hyperopia, sponsored by Alcon Research. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 92
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.

Read the detailed description

Subjects will be expected to attend 7 visits including a screening visit. The total duration of a subject's participation in the study will be approximately 40 days.

Conditions studied

Ametropia
Myopia
Hyperopia
Astigmatism

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In context

Refractive Errors

420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.

This study's enrollment of 92 is above the median of 76 across 301 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.

Browse Alcon Research studies →All Alcon studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable lenses) in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
Able to be fit with and wear contact lenses within the available range of sphere \& cylinder power and axes.
Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening.
Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months).
Other exclusion criteria may apply.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 92 participants (actual)

Study arms

Other
LID226397, then AOfAHP
Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Device: Serafilcon A toric contact lenses · Device: Senofilcon A toric contact lenses · Device: CLEAR CARE
Other
AOfAHP, then LID226397
Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Device: Serafilcon A toric contact lenses · Device: Senofilcon A toric contact lenses · Device: CLEAR CARE

Interventions

DeviceSerafilcon A toric contact lenses
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
Also known as: LID226397
DeviceSenofilcon A toric contact lenses
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
Also known as: ACUVUE® OASYS for ASTIGMATISM with HYDRACLEAR® PLUS, AOfAHP
DeviceCLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Also known as: CLEAR CARE® Cleaning and Disinfecting Solution

What researchers measure

Primary outcomes

Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion
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.
Time frame: 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 Nov 29, 2024

Participant flow

Participants were recruited from 7 investigative sites located in 1 country (US).

First Wear Period (Approx. 14 Days)

Participant flow — First Wear Period (Approx. 14 Days)
Milestone	LID226397, Then AOfAHP	AOfAHP, Then LID226397
Started	48	44
Completed	48	44
Not completed	0	0

Second Wear Period (Approx. 14 Days)

Participant flow — Second Wear Period (Approx. 14 Days)
Milestone	LID226397, Then AOfAHP	AOfAHP, Then LID226397
Started	48	44
Completed	48	44
Not completed	0	0

Outcome measures

PrimaryPercentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion

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.

Time frame:: Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment.
Reported as:: Number · percentage of lenses

Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion
percentage of lenses	LID226397	AOfAHP
Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion	100.0	100.0

Adverse events

Collected over Adverse Events (AEs) were collected from time of consent to study exit, up to 40 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
LID226397 Ocular	0/184 (0%)	0/184 (0%)	0/184 (0%)
LID226397 Nonocular	0/92 (0%)	0/92 (0%)	0/92 (0%)
AOfAHP Ocular	0/184 (0%)	0/184 (0%)	0/184 (0%)
AOfAHP Nonocular	0/92 (0%)	0/92 (0%)	0/92 (0%)

Baseline characteristics

Full Analysis Set: All randomized subjects/eyes exposed to any study lenses evaluated in this study.

Age, Continuous
Age, Continuous(years)	LID226397, Then AOfAHP	AOfAHP, Then LID226397	Total
Mean	32.7 ± 9.7	32.0 ± 9.6	32.3 ± 9.6

Sex: Female, Male
Sex: Female, Male(Participants)	LID226397, Then AOfAHP	AOfAHP, Then LID226397	Total
Female	22	33	55
Male	26	11	37

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	LID226397, Then AOfAHP	AOfAHP, Then LID226397	Total
White	35	29	64
Black or African American	2	3	5
American Indian or Alaska Native	0	0	0
Asian	11	10	21
Native Hawaiian or Other Pacific Islander	0	0	0
Other	0	1	1
Multi-racial	0	1	1

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	LID226397, Then AOfAHP	AOfAHP, Then LID226397	Total
Hispanic or Latino	5	10	15
Not Hispanic or Latino	43	33	76
Not Reported	0	1	1

Study locations

7 sites

Dr. Elsa Pao, OD
Oakland, California 94607, United States
Pacific Rims Optometry
San Francisco, California 94127, United States
Drs. Giedd, P.A.
Maitland, Florida 32751, United States
Vision Health Institute
Orlando, Florida 32803, United States
Franklin Park Eye Center, PC
Franklin Park, Illinois 60131, United States
ProCare Vision Centers, Inc.
Granville, Ohio 43023, United States
Optometry Group, PLLC
Memphis, Tennessee 38111, United States

References and documents

Study documents

Study protocol ↗ · Sep 6, 2023
Statistical analysis plan ↗ · Sep 13, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2023 to primary completion in Oct 2023, 2 months.

Results were first posted in Nov 2024, 1 year 1 month after primary completion.

Of 115 industry-sponsored interventional studies with no phase under Refractive Errors, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 10. This study's 2 months is below that.

Counting every sponsor, half of 172 studies reached it within 7 months; a quarter within 2 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 13, 2023
First posted: Jul 25, 2023
StartActual: Aug 14, 2023
Primary completionActual: Oct 23, 2023
CompletionActual: Oct 23, 2023
Results first posted: Nov 29, 2024
Last update: Nov 29, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05959200
Lead sponsor: Alcon Research
Responsible party: Sponsor
First posted: Jul 25, 2023
Start date: Aug 14, 2023
Primary completion: Oct 23, 2023
Completion: Oct 23, 2023
Results posted: Nov 29, 2024
Last update: Nov 29, 2024

Study contacts

Clinical Trial Lead, CRD Vision Care

study director · Alcon Research, LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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