CompletedNCT03169153Updated Jul 25, 2019Results posted

Clinical Comparison of Silicone Hydrogel Monthly Lenses

An interventional study of Lotrafilcon B contact lenses and Senofilcon C contact lenses in Refractive Error, sponsored by Alcon Research. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-25.

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

Phase: Not applicable
Study type: Interventional
Enrollment: 114
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors.

Conditions studied

Refractive Error

Browse trials for

Refractive Errors 427

Keywords

contact lenses
lipids
deposits

In context

Refractive Errors

427 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 114 is above the median of 81 across 307 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 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Sign Informed Consent;
Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1;
Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1;
Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses;
Screening lenses worn 10 hours exhibiting high lipid uptake.

Exclusion criteria

Exclusion Criteria:

Habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months;
Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months;
Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current)
History of herpetic keratitis, corneal surgery, or irregular cornea;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
Abnormal ocular conditions or findings, as specified in the protocol;
Known pregnancy and lactation.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 114 participants (actual)

Study arms

Other
Lotrafilcon B, then senofilcon C
Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
Device: Lotrafilcon B contact lenses · Device: Senofilcon C contact lenses
Other
Senofilcon C, then lotrafilcon B
Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
Device: Lotrafilcon B contact lenses · Device: Senofilcon C contact lenses

Interventions

DeviceLotrafilcon B contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Also known as: AIR OPTIX® plus HydraGlyde
DeviceSenofilcon C contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Also known as: ACUVUE® VITA®

What researchers measure

Primary outcomes

Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens
Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis.
Time frame: Day 30 after 10 hours of wear, each product

Results

Posted Jul 25, 2019

Participant flow

Subjects were recruited from 1 study center located in the United Kingdom.

Period 1, First 30 Days of Wear

Participant flow — Period 1, First 30 Days of Wear
Milestone	AOHG Then VITA	VITA Then AOHG
Started	42	39
Completed	39	35
Not completed	3	4
Withdrew: Lost to follow-up	1	1
Withdrew: Withdrawal by subject	2	3

Period 2, Second 30 Days of Wear

Participant flow — Period 2, Second 30 Days of Wear
Milestone	AOHG Then VITA	VITA Then AOHG
Started	39	34
Completed	37	32
Not completed	2	2
Withdrew: Adverse event	1	2
Withdrew: Could not attend visit	1	0

Outcome measures

PrimaryMean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens

Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis.

Time frame:: Day 30 after 10 hours of wear, each product
Reported as:: Mean · micrograms (μg)

Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens
micrograms (μg)	AOHG	VITA
Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens	78.1398 ± 70.7923	307.6800 ± 303.9299

Statistical analysis

AOHG vs VITA · Mixed effects repeated measures · p = <0.0001

Adverse events

Collected over Dispense through study completion, an average of 2.5 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AOHG	0/76 (0%)	0/76 (0%)	0/76 (0%)
VITA	0/78 (0%)	0/78 (0%)	0/78 (0%)

Baseline characteristics

This analysis population includes all randomized subjects who were exposed to AOHG or VITA lenses (Full Analysis Set).

Age, Continuous
Age, Continuous(years)	Overall
Mean	32.3 ± 9.8

Sex: Female, Male
Sex: Female, Male(Participants)	Overall
Female	60
Male	21

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Overall

Study locations

1 site

Alcon Investigative Site
London, SW1E 6AU, United Kingdom

References and documents

Study documents

Study protocol · Dec 7, 2017
Statistical analysis plan · Jul 3, 2018

Documents are hosted by the registry — open the source record to download them.

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 Sep 2017 to primary completion in Jul 2018, 9 months.

Results were first posted in Jul 2019, 1 year after primary completion.

Of 122 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 9 months is above that.

Counting every sponsor, half of 174 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: May 25, 2017
First posted: May 30, 2017
StartActual: Sep 22, 2017
Primary completionActual: Jul 19, 2018
CompletionActual: Jul 19, 2018
Results first posted: Jul 25, 2019
Last update: Jul 25, 2019

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 Jul 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03169153
Lead sponsor: Alcon Research
Responsible party: Sponsor
First posted: May 30, 2017
Start date: Sep 22, 2017
Primary completion: Jul 19, 2018
Completion: Jul 19, 2018
Results posted: Jul 25, 2019
Last update: Jul 25, 2019

Study contacts

Clinical Manager, Medical Clinical Trial Services

study director · Alcon Research

Oversight

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 May 2019. You cannot join it, but the record below documents what was studied.

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