Refractive ErrorsNCT05056987
Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses
A study testing Lehfilcon A contact lenses, Senofilcon A contact lenses and AOSEPT PLUS with HydraGlyde in people with Refractive Errors, run by Alcon Research at 1 site in United Kingdom.
Trial summary
The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Lehfilcon A contact lenses, Senofilcon A contact lenses and AOSEPT PLUS with HydraGlyde
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jan 2022to 14 Jun 2022
- 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
- Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience.
- Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day.
- Willing to NOT use rewetting/lubricating drops at any time during the study.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial.
- Habitual AOHP contact lens wearers (in the past 3 months).
- Monovision wear during the study.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.
Read the detailed description
Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).
- Conditions
- Refractive Errors
- Being tested
- Lehfilcon A contact lenses, Senofilcon A contact lenses, AOSEPT PLUS with HydraGlyde
- Keywords
- Contact Lenses, Myopia
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lehfilcon A contact lensesDevice
Also called TOTAL30®
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
Senofilcon A contact lensesDevice
Also called ACUVUE OASYS® with HYDRACLEAR® Plus, AOHP
CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
AOSEPT PLUS with HydraGlydeDevice
Also called AOSEPT® PLUS with HYDRAGLYDE®
Hydrogen peroxide-based cleaning and disinfecting solution
| Study group | Role | What they receive |
|---|---|---|
| TOTAL30, then AOHP | Other | Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses will be worn for approximately 28 days. The senofilcon A contact lenses will be worn for approximately 14 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. Receives: Device: Lehfilcon A contact lenses; Device: Senofilcon A contact lenses; Device: AOSEPT PLUS with HydraGlyde |
| AOHP, then TOTAL30 | Other | Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses will be worn for approximately 14 days. The lehfilcon A contact lenses will be worn for approximately 28 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. Receives: Device: Lehfilcon A contact lenses; Device: Senofilcon A contact lenses; Device: AOSEPT PLUS with HydraGlyde |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance VA (logMAR) With Study Lenses
Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Measured: Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start12 Jan 2022
- Primary completion14 Jun 2022
- Study completion14 Jun 2022
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 ErrorsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056987
- Sponsor's protocol ID
- CLY935-C018
- Status last verified
- May 2023
- First submitted
- 15 Sep 2021
- Last updated
- 18 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT05056987
- Acronym / sponsor ID
- CLY935-C018
- Conditions
- Refractive Errors
- Keywords
- Contact Lenses, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Posted 18 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.
Detailed description
Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOTAL30, then AOHP | Other | Device: Lehfilcon A contact lenses, Device: Senofilcon A contact lenses, Device: AOSEPT PLUS with HydraGlydeLehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses will be worn for approximately 28 days. The senofilcon A contact lenses will be worn for approximately 14 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. |
| AOHP, then TOTAL30 | Other | Device: Lehfilcon A contact lenses, Device: Senofilcon A contact lenses, Device: AOSEPT PLUS with HydraGlydeSenofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses will be worn for approximately 14 days. The lehfilcon A contact lenses will be worn for approximately 28 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience.
- Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day.
- Willing to NOT use rewetting/lubricating drops at any time during the study.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial.
- Habitual AOHP contact lens wearers (in the past 3 months).
- Monovision wear during the study.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Lehfilcon A contact lensesAlso: TOTAL30®CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use | Device | AOHP, then TOTAL30, TOTAL30, then AOHP |
| Senofilcon A contact lensesAlso: ACUVUE OASYS® with HYDRACLEAR® Plus, AOHPCE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use | Device | AOHP, then TOTAL30, TOTAL30, then AOHP |
| AOSEPT PLUS with HydraGlydeAlso: AOSEPT® PLUS with HYDRAGLYDE®Hydrogen peroxide-based cleaning and disinfecting solution | Device | AOHP, then TOTAL30, TOTAL30, then AOHP |
Primary outcome
Distance VA (logMAR) With Study Lenses
Time frame: Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)
Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Clinical Trial Lead, Vision Care study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lehfilcon A contact lenses, Senofilcon A contact lenses and AOSEPT PLUS with HydraGlyde in people with Refractive Errors, run by Alcon Research at 1 site in United Kingdom.
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 4 inclusion and 4 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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 18 Jun 2023). 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?
Distance VA (logMAR) With Study Lenses (time frame: Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)). 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 18 Jun 2023.