Refractive AmetropiaNCT04085328
Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
A study testing LID015385 soft contact lenses and Comfilcon A soft contact lenses in people with Refractive Ametropia, run by Alcon Research at 42 sites in United States.
Trial summary
The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Ametropia
- What is being tested?
- LID015385 soft contact lenses and Comfilcon A soft contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 42 sitesUnited States
- Study dates
- 11 Oct 2019to 26 Mar 2021
- 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 Informed Consent Form.
- Willing to attend all scheduled study visits as required per protocol.
- Willing and able to wear assigned study lenses as required per protocol.
- Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
- Manifest cylinder ≤ 0.75 diopter (D) in each eye.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- History of eye surgery, including refractive surgery.
- Currently pregnant or breast-feeding.
- Monovision contact lens wearers.
- Daily disposable contact lens wearers.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Asheville Eye Associates, PLLC
Asheville, North Carolina, 28803
Beaumont Family Eye Care
Beaumont, Texas, 77706
VisionPoint Eye Center
Bloomington, Illinois, 61704
North Spartanburg Eye Center
Boiling Springs, South Carolina, 29316
Primary Eyecare Group, PC
Brentwood, Tennessee, 37027
Optimum Vision Care
Brighton, Massachusetts, 02135
Family EyeCare Center
Campbell, California, 95008
Franklin Park Eye Center, PC
Franklin Park, Illinois, 60131
Fraser Eye Care Center
Fraser, Michigan, 48026
Winston Eye Care
Fullerton, California, 92835
ProCare Vision Centers, Inc.
Granville, Ohio, 43023
Vision One Eyecare
Katy, Texas, 77450
OMEGA Vision Center PA, DBA Sabal Eye Care
Longwood, Florida, 32779
Kurata Eye Care Center
Los Angeles, California, 90012
East West Eye Institute
Los Angeles, California, 90013
Kindred Optics at Maitland Vision Center
Maitland, Florida, 32751
Complete Eye Care of Medina
Medina, Minnesota, 55340
Optometry Group, PLLC
Memphis, Tennessee, 38111
Total Eye Care, PA
Memphis, Tennessee, 38119
Mid Florida Eye Center, PA
Mt. Dora, Florida, 32757
Dr.Elsa Pao, O.D
Oakland, California, 94607
Eola Eyes
Orlando, Florida, 32803
Vision Health Institute
Orlando, Florida, 32803
Visual Performance Center Research & Development
Pensacola, Florida, 32503
Midwest Vision Care
Piqua, Ohio, 45356
Kannarr Eye Care, LLC
Pittsburg, Kansas, 66762
Alterman, Modi & Wolter
Poughkeepsie, New York, 12603
EyeCare Professionals, Inc. DBA Insight Research Clinic, LLC
Powell, Ohio, 43065
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
Dawn M Rakich, OD
San Antonio, Texas, 78213
Gordon Schanzlin New Vision Institute
San Diego, California, 92122
Complete Family Vision Care
San Diego, California, 92123
Westview Optometry
San Diego, California, 92129
Golden Vision
Sarasota, Florida, 34237
Advancing Vision Research, LLC
Smyrna, Tennessee, 37167
Tekwnai Vision Center, Inc
St Louis, Missouri, 63128
Dr. Schwartz Optometrist and Associates
Sterling Heights, Michigan, 48312
West Bay Eye Associates
Warwick, Rhode Island, 02888
Advanced Eyecare Specialists
West Palm Beach, Florida, 33405
Clarke EyeCare Center
Wichita Falls, Texas, 76308
Fischer Laser Eye Center, LLC
Willmar, Minnesota, 56201
Wyomissing Optometric Center
Wyomissing, Pennsylvania, 19610
About this study
Official title: Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.
Read the detailed description
Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.
- Conditions
- Refractive Ametropia
- Being tested
- LID015385 soft contact lenses, Comfilcon A soft contact lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LID015385 soft contact lensesDevice
Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
Comfilcon A soft contact lensesDevice
Also called BIOFINITY®
Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
| Study group | Role | What they receive |
|---|---|---|
| LID015385 | Experimental | LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol. Receives: Device: LID015385 soft contact lenses |
| Biofinity | Active comparator | Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol. Receives: Device: Comfilcon A soft contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
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 lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Measured: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
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 lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Measured: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up
Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)
Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).
Measured: Up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start11 Oct 2019
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon Study Director, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085328
- Sponsor's protocol ID
- CLL949-C010
- Status last verified
- May 2023
- First submitted
- 9 Sep 2019
- Last updated
- 13 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 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
- ClinicalTrials.gov ID
- NCT04085328
- Acronym / sponsor ID
- CLL949-C010
- Conditions
- Refractive Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Posted 13 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 purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.
Detailed description
Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LID015385 | Experimental | Device: LID015385 soft contact lensesLID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol. |
| Biofinity | Active comparator | Device: Comfilcon A soft contact lensesComfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to understand and sign an Informed Consent Form.
- Willing to attend all scheduled study visits as required per protocol.
- Willing and able to wear assigned study lenses as required per protocol.
- Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
- Manifest cylinder ≤ 0.75 diopter (D) in each eye.
Key exclusion criteria (7 listed)
- Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- History of eye surgery, including refractive surgery.
- Currently pregnant or breast-feeding.
- Monovision contact lens wearers.
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 |
|---|---|---|
| LID015385 soft contact lensesInvestigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear | Device | LID015385 |
| Comfilcon A soft contact lensesAlso: BIOFINITY®Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear | Device | Biofinity |
Primary outcome
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Time frame: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up
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 lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Time frame: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up
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 lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)
Time frame: Up to Month 12
Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
Alcon Study Director study director
Alcon Research
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LID015385 soft contact lenses and Comfilcon A soft contact lenses in people with Refractive Ametropia, run by Alcon Research at 42 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 6 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 13 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 42 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 13 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 Visual Acuity (VA) With Study Lenses - Completed Eyes (time frame: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up). The study lists 3 primary outcomes in all. 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 13 Jun 2023.