Refractive ErrorsNCT05725317
Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses
A study testing LID220365 contact lens and LID006961 contact lens in people with Refractive Errors and Myopia, run by Alcon Research at 7 sites in United States.
Trial summary
The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors, Myopia
- What is being tested?
- LID220365 contact lens and LID006961 contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Jun 2023to 27 Jun 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 wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
- 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 monovision or multifocal contact lens wearers.
- Other protocol-specified 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
Kindred Optics at Maitland Vision
Maitland, Florida, 32751
Optometry Group, PLLC
Memphis, Tennessee, 38111
SUNY College of Optometry Clinical Vision Research Center
New York, New York, 10036
Vision Health Institute
Orlando, Florida, 32803
Clarke Eyecare Center
Wichita Falls, Texas, 76308
Wyomissing Optometric Center
Wyomissing, Pennsylvania, 19610
About this study
The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.
Read the detailed description
The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.
- Conditions
- Refractive Errors, Myopia
- Being tested
- LID220365 contact lens, LID006961 contact lens
- 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.
LID220365 contact lensDevice
Investigational delefilcon A spherical contact lens made with a modified manufacturing process
LID006961 contact lensDevice
Also called DAILIES TOTAL1®
Commercially available delefilcon A spherical contact lens
| Study group | Role | What they receive |
|---|---|---|
| LID220365 (OD) / LID006961 (OS) | Other | LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day. Receives: Device: LID220365 contact lens; Device: LID006961 contact lens |
| LID006961 (OD) / LID220365 (OS) | Other | LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day. Receives: Device: LID220365 contact lens; Device: LID006961 contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4
VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. 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 a lower logMAR value indicating better visual acuity.
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start2 Jun 2023
- Primary completion27 Jun 2023
- Study completion27 Jun 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 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 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
- NCT05725317
- Sponsor's protocol ID
- CLX679-C001
- Status last verified
- Jul 2024
- First submitted
- 3 Feb 2023
- Last updated
- 6 Aug 2024
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT05725317
- Acronym / sponsor ID
- CLX679-C001
- Conditions
- Refractive Errors, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Posted 6 Aug 2024
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 assess the overall clinical performance of a contact lens made with a modified manufacturing process.
Detailed description
The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LID220365 (OD) / LID006961 (OS) | Other | Device: LID220365 contact lens, Device: LID006961 contact lensLID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day. |
| LID006961 (OD) / LID220365 (OS) | Other | Device: LID220365 contact lens, Device: LID006961 contact lensLID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day. |
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 wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
- 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 monovision or multifocal contact lens wearers.
- Other protocol-specified 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 |
|---|---|---|
| LID220365 contact lensInvestigational delefilcon A spherical contact lens made with a modified manufacturing process | Device | LID006961 (OD) / LID220365 (OS), LID220365 (OD) / LID006961 (OS) |
| LID006961 contact lensAlso: DAILIES TOTAL1®Commercially available delefilcon A spherical contact lens | Device | LID006961 (OD) / LID220365 (OS), LID220365 (OD) / LID006961 (OS) |
Primary outcome
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4
Time frame: Day 4
VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. 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 a lower logMAR value indicating better visual acuity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 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, 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 LID220365 contact lens and LID006961 contact lens in people with Refractive Errors 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 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 6 Aug 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 6 Aug 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?
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4 (time frame: Day 4). 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 6 Aug 2024.