Refractive ErrorNCT02696317
Clinical Evaluation of ACUVUE® OASYS® 1-Day and ACUVUE® OASYS®
A study testing Senofilcon A contact lenses with HydraLuxe™ and Senofilcon A contact lenses in people with Refractive Error, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Error
- What is being tested?
- Senofilcon A contact lenses with HydraLuxe™ and Senofilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2016to 6 Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must sign an informed consent form;
- Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months;
- Prescription within power range of both study contact lenses, as stated in the protocol;
- Cylinder equal or lower than -0.75 diopter (D) in both eyes;
- Willing to wear lenses every day or at least a minimum of 5 days per week, 6 hours per day;
- Willing to discontinue artificial tears and rewetting drops on the days of study visits;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Pregnant or lactating;
- Current AO1D or AO lens wearer;
- Other protocol-specified exclusion criteria may apply.
About this study
Official title: Clinical Evaluation of ACUVUE® OASYS® 1-Day Daily Disposable Silicone Hydrogel Contact Lenses
The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear.
Read the detailed description
After randomization to lens order, subjects attended study visits that included a 3 hour exposure to reduced humidity environment (20% relative humidity) and subsequent tear film assessments for each study lens.
- Conditions
- Refractive Error
- Being tested
- Senofilcon A contact lenses with HydraLuxe™, Senofilcon A contact lenses
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senofilcon A contact lenses with HydraLuxe™Device
Also called ACUVUE® OASYS® 1-Day Contact Lenses with HydraLuxe™ (AO1D)
Contact lenses worn during Period 1 or 2, as randomized
Senofilcon A contact lensesDevice
Also called ACUVUE® OASYS® (AO)
Contact lenses worn during Period 1 or 2, as randomized
| Study group | Role | What they receive |
|---|---|---|
| AO1D, then AO | Other | Senofilcon A contact lenses with HydraLuxe™, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality. Receives: Device: Senofilcon A contact lenses with HydraLuxe™; Device: Senofilcon A contact lenses |
| AO, then AO1D | Other | Senofilcon A contact lenses, followed by senofilcon A contact lenses with HydraLuxe™. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality. Receives: Device: Senofilcon A contact lenses with HydraLuxe™; Device: Senofilcon A contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Measured: Day 10 ± 3 days, each product
Secondary outcomes (3)
Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 6 hours of lens wear, including 3 hours of wear in a 20% reduced humidity environment (20% RH), after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Measured: Day 10 ± 3 days, each product
Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed in a normal environment following 3 hours of wear. Higher values indicate less dry and more eye comfort.
Measured: Day 10 ± 3 days, each product
Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed following 6 hours of wear including 3 hours in a reduced humidity environment (20% RH).. Higher values indicate less dry and more eye comfort.
Measured: Day 10 ± 3 days, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study start18 Mar 2016
- Primary completion6 Jun 2016
- Study completion6 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Clinical Manager, GCRA Operations, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696317
- Sponsor's protocol ID
- CLE198-P001
- Status last verified
- Sep 2017
- First submitted
- 24 Feb 2016
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of ACUVUE® OASYS® 1-Day Daily Disposable Silicone Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT02696317
- Acronym / sponsor ID
- CLE198-P001
- Conditions
- Refractive Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2016 (actual)
- Primary completion
- 6 Jun 2016 (actual)
- Study completion
- 6 Jun 2016 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear.
Detailed description
After randomization to lens order, subjects attended study visits that included a 3 hour exposure to reduced humidity environment (20% relative humidity) and subsequent tear film assessments for each study lens.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AO1D, then AO | Other | Device: Senofilcon A contact lenses with HydraLuxe™, Device: Senofilcon A contact lensesSenofilcon A contact lenses with HydraLuxe™, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality. |
| AO, then AO1D | Other | Device: Senofilcon A contact lenses with HydraLuxe™, Device: Senofilcon A contact lensesSenofilcon A contact lenses, followed by senofilcon A contact lenses with HydraLuxe™. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must sign an informed consent form;
- Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months;
- Prescription within power range of both study contact lenses, as stated in the protocol;
- Cylinder equal or lower than -0.75 diopter (D) in both eyes;
- Willing to wear lenses every day or at least a minimum of 5 days per week, 6 hours per day;
Key exclusion criteria (7 listed)
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Pregnant or lactating;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senofilcon A contact lenses with HydraLuxe™Also: ACUVUE® OASYS® 1-Day Contact Lenses with HydraLuxe™ (AO1D)Contact lenses worn during Period 1 or 2, as randomized | Device | AO, then AO1D, AO1D, then AO |
| Senofilcon A contact lensesAlso: ACUVUE® OASYS® (AO)Contact lenses worn during Period 1 or 2, as randomized | Device | AO, then AO1D, AO1D, then AO |
Primary outcome
Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
Time frame: Day 10 ± 3 days, each product
Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
3 secondary outcomes
Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
Time frame: Day 10 ± 3 days, each product
Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
Time frame: Day 10 ± 3 days, each product
Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
Time frame: Day 10 ± 3 days, each product
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senior Clinical Manager, GCRA Operations study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Senofilcon A contact lenses with HydraLuxe™ and Senofilcon A contact lenses in people with Refractive Error, run by Alcon Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH) (time frame: Day 10 ± 3 days, each product). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.