AmetropiaNCT05959200
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses
A study testing Serafilcon A toric contact lenses, Senofilcon A toric contact lenses and CLEAR CARE in people with Ametropia and Myopia, run by Alcon Research at 7 sites in United States.
Trial summary
The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Serafilcon A toric contact lenses, Senofilcon A toric contact lenses and CLEAR CARE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Aug 2023to 23 Oct 2023
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Franklin Park Eye Center, PC
Franklin Park, Illinois, 60131
ProCare Vision Centers, Inc.
Granville, Ohio, 43023
Drs. Giedd, P.A.
Maitland, Florida, 32751
Optometry Group, PLLC
Memphis, Tennessee, 38111
Dr. Elsa Pao, OD
Oakland, California, 94607
Vision Health Institute
Orlando, Florida, 32803
Pacific Rims Optometry
San Francisco, California, 94127
About this study
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
- Ametropia, Myopia, Hyperopia, Astigmatism
- Being tested
- Serafilcon A toric contact lenses, Senofilcon A toric contact lenses, CLEAR CARE
- Medical subject headings
- Refractive Errors, Myopia, Hyperopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serafilcon A toric contact lensesDevice
Also called LID226397
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
Senofilcon A toric contact lensesDevice
Also called ACUVUE® OASYS for ASTIGMATISM with HYDRACLEAR® PLUS, AOfAHP
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
CLEAR CAREDevice
Also called CLEAR CARE® Cleaning and Disinfecting Solution
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
| Study group | Role | What they receive |
|---|---|---|
| LID226397, then AOfAHP | Other | 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. Receives: Device: Serafilcon A toric contact lenses; Device: Senofilcon A toric contact lenses; Device: CLEAR CARE |
| AOfAHP, then LID226397 | Other | 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. Receives: Device: Serafilcon A toric contact lenses; Device: Senofilcon A toric contact lenses; Device: CLEAR CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start14 Aug 2023
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
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 AmetropiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, CRD Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959200
- Sponsor's protocol ID
- CLN109-C001
- Status last verified
- Oct 2024
- First submitted
- 13 Jul 2023
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT05959200
- Acronym / sponsor ID
- CLN109-C001
- Conditions
- Ametropia, Myopia, Hyperopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LID226397, then AOfAHP | Other | Device: Serafilcon A toric contact lenses, Device: Senofilcon A toric contact lenses, Device: CLEAR CARESerafilcon 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. |
| AOfAHP, then LID226397 | Other | Device: Serafilcon A toric contact lenses, Device: Senofilcon A toric contact lenses, Device: CLEAR CARESenofilcon 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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.
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 |
|---|---|---|
| Serafilcon A toric contact lensesAlso: LID226397Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) | Device | AOfAHP, then LID226397, LID226397, then AOfAHP |
| Senofilcon A toric contact lensesAlso: ACUVUE® OASYS for ASTIGMATISM with HYDRACLEAR® PLUS, AOfAHPSilicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) | Device | AOfAHP, then LID226397, LID226397, then AOfAHP |
| CLEAR CAREAlso: CLEAR CARE® Cleaning and Disinfecting SolutionHydrogen peroxide-based contact lens cleaning and disinfecting solution | Device | AOfAHP, then LID226397, LID226397, then AOfAHP |
Primary outcome
Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- 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, CRD Vision Care study director
Alcon Research, LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serafilcon A toric contact lenses, Senofilcon A toric contact lenses and CLEAR CARE in people with Ametropia and Myopia, run by Alcon Research at 7 sites in United States.
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 3 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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 29 Nov 2024). 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?
Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion (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.). 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 29 Nov 2024.