Refractive ErrorsNCT04403542
Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
A study testing Lehfilcon A contact lens and Comfilcon A contact lens in people with Refractive Errors and Myopia, run by Alcon Research at 3 sites in United States.
Trial summary
The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors, Myopia, Hyperopia
- What is being tested?
- Lehfilcon A contact lens and Comfilcon A contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Aug 2020to 31 Aug 2020
- 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
- Able to understand and sign an IRB/IEC approved Informed Consent form.
- Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
- Best corrected visual acuity of 20/25 or better in each eye.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
- Any habitual wear of Biofinity contact lenses.
- Pregnant or breast-feeding.
- Other protocol specified exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Alcon Investigator 8046
Granville, Ohio, 43023
Alcon Investigator 6402
Medina, Minnesota, 55340
Alcon Investigator 2786
Memphis, Tennessee, 38119
About this study
The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.
Read the detailed description
Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.
- Conditions
- Refractive Errors, Myopia, Hyperopia
- Being tested
- Lehfilcon A contact lens, Comfilcon A contact lens
- Keywords
- Extended Wear, Contact Lens, Overnight Wear, Vision Correction, Contralateral Wear
- Medical subject headings
- Refractive Errors, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lehfilcon A contact lensDevice
Also called LID018869
Investigational silicone hydrogel contact lens
Comfilcon A contact lensDevice
Also called Biofinity
Commercially available silicone hydrogel contact lens
| Study group | Role | What they receive |
|---|---|---|
| LID018869 (OD) / Biofinity (OS) | Experimental | Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear Receives: Device: Lehfilcon A contact lens; Device: Comfilcon A contact lens |
| Biofinity (OD) / LID018869 (OS) | Active comparator | Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear Receives: Device: Lehfilcon A contact lens; Device: Comfilcon A contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity (VA) With Study Lenses
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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. No formal hypothesis testing was planned.
Measured: Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start3 Aug 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
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
- Model description
- In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CDMA Project Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403542
- Sponsor's protocol ID
- CLY935-C008
- Status last verified
- Aug 2023
- First submitted
- 21 May 2020
- Last updated
- 22 Aug 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 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
- ClinicalTrials.gov ID
- NCT04403542
- Acronym / sponsor ID
- CLY935-C008
- Conditions
- Refractive Errors, Myopia, Hyperopia
- Keywords
- Extended Wear, Contact Lens, Overnight Wear, Vision Correction, Contralateral Wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Posted 22 Aug 2023
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 clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.
Detailed description
Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
| Arm | Type | Receives |
|---|---|---|
| LID018869 (OD) / Biofinity (OS) | Experimental | Device: Lehfilcon A contact lens, Device: Comfilcon A contact lensLehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear |
| Biofinity (OD) / LID018869 (OS) | Active comparator | Device: Lehfilcon A contact lens, Device: Comfilcon A contact lensComfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to understand and sign an IRB/IEC approved Informed Consent form.
- Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
- Best corrected visual acuity of 20/25 or better in each eye.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
- Any habitual wear of Biofinity contact lenses.
- Pregnant or breast-feeding.
- 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 |
|---|---|---|
| Lehfilcon A contact lensAlso: LID018869Investigational silicone hydrogel contact lens | Device | Biofinity (OD) / LID018869 (OS), LID018869 (OD) / Biofinity (OS) |
| Comfilcon A contact lensAlso: BiofinityCommercially available silicone hydrogel contact lens | Device | Biofinity (OD) / LID018869 (OS), LID018869 (OD) / Biofinity (OS) |
Primary outcome
Distance Visual Acuity (VA) With Study Lenses
Time frame: Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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. No formal hypothesis testing was planned.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Refractive Errors
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
CDMA Project Lead, Vision Care study director
Alcon Research, LLC
3 sites 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 lens and Comfilcon A contact lens in people with Refractive Errors and Myopia, run by Alcon Research at 3 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 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 22 Aug 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 Visual Acuity (VA) With Study Lenses (time frame: Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit). 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 22 Aug 2023.