Refractive ErrorsNCT06884202
Evaluation of Delefilcon A Contact Lenses
A study testing Delefilcon A contact lenses with different base curves and diameters and Delefilcon A contact lenses with standard base curves and diameters in people with Refractive Errors and Myopia, run by Alcon Research at 16 sites in United States.
Trial summary
The purpose of the study is to evaluate the lens fit characteristics of delefilcon A contact lenses with different base curves and diameters. 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?
- Delefilcon A contact lenses with different base curves and diameters and Delefilcon A contact lenses with standard base curves and diameters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 16 sitesUnited States
- Study dates
- 28 Apr 2025to 26 Aug 2025
- 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 in both eyes for a minimum of 5 days per week and a minimum of 6 hours per day during the past 3 months;
- Able to wear contact lenses within a range of sphere powers from -2.00 and -4.00 diopters (D);
- Best Corrected Visual Acuity (BCVA) (with manifest refraction) better than or equal to 0.10 logarithm Minimum Angle of Resolution (logMAR ) in each eye.
Who cannot join
- Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
- History of refractive surgery or plan to have refractive surgery during the study, or irregular cornea in either eye;
- Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
NC Eye Associates, OD, PLLC
Apex, North Carolina, 27502
See Eye Care Optometry
Charlotte, North Carolina, 28278
Coldwater Vision Research
Coldwater, Mississippi, 38618
Eyeconic Family Eyecare
Dallas, Georgia, 30157
ProCare Vision Centers, Inc.
Granville, Ohio, 43023
Pearson Research Center, PA
Longwood, Florida, 32779
Kurata Eyecare Center
Los Angeles, California, 90013
Kindred Optics at Maitland Vision
Maitland, Florida, 32751
Southern College of Optometry
Memphis, Tennessee, 38104
SUNY College of Optometry Clinical Vision Research Center
New York, New York, 10036
Elsa Pao, OD
Oakland, California, 94607
Eyecare Professionals, Inc
Powell, Ohio, 43065
Pacific Rims Optometry
San Francisco, California, 94127
Dr. Schwartz Optometrist and Associates
Sterling Heights, Michigan, 48312
West Bay Eye Associates
Warwick, Rhode Island, 02888
Wyomissing Optometric Center
Wyomissing, Pennsylvania, 19610
About this study
Official title: Clinical Evaluation of Overall Lens Fit of Delefilcon A Contact Lenses of Different Diameters and Base Curves
The purpose of the study is to evaluate the lens fit characteristics of delefilcon A contact lenses with different base curves and diameters.
Read the detailed description
Subjects will be expected to attend 4 office visits for an individual duration of participation of approximately 3 days.
- Conditions
- Refractive Errors, Myopia
- Being tested
- Delefilcon A contact lenses with different base curves and diameters, Delefilcon A contact lenses with standard base curves and diameters
- Keywords
- Contact lenses
- 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.
Delefilcon A contact lenses with different base curves and diametersDevice
Also called LID023681
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
Delefilcon A contact lenses with standard base curves and diametersDevice
Also called DAILIES TOTAL1®, LID006961
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
| Study group | Role | What they receive |
|---|---|---|
| LID023681, then LID006961 | Other | Delefilcon A contact lenses with different base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with standard base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods. Receives: Device: Delefilcon A contact lenses with different base curves and diameters; Device: Delefilcon A contact lenses with standard base curves and diameters |
| LID006961, then LID023681 | Other | Delefilcon A contact lenses with standard base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with different base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods. Receives: Device: Delefilcon A contact lenses with different base curves and diameters; Device: Delefilcon A contact lenses with standard base curves and diameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in Lens Movement (Overall Lens Fit) at Primary Gaze
Lens movement was evaluated by the investigator using a slit lamp with the eye in primary gaze (looking straight ahead). Subject was asked to blink after which the investigator pushed up the lower lid margin to evaluate lens movement. Lens movement was graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Measured: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in Lens Movement (Overall Lens Fit) at Peripheral Gazes
Lens movement was evaluated by the investigator using a slit lamp with the eye in peripheral gaze (upward gaze, downward gaze, looking to the left, and looking to the right). Lens movement was assessed for each gaze on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). The overall lens fit grade was based on the worst-case scenario among the different gazes. A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Measured: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Proportion of Lenses Graded as Optimal Lens Centration or Acceptable Decentration at Dispense in Lens Position (Centration)
Lens position was evaluated by the investigator using a slit lamp with the eye in primary position (relaxed, looking straight ahead). Lens position was graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable decentration; 2 = Unacceptable decentration. A grade of Optimal Centration or Acceptable Decentration is considered to be acceptable centration.
Measured: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in Lens Movement (Overall Fit) at Primary Gaze
Lens movement was evaluated by the investigator using a slit lamp with the eye in primary gaze (looking straight ahead). Subject was asked to blink after which the investigator pushed up the lower lid margin to evaluate lens movement. Lens movement was graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Measured: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in Lens Movement (Overall Fit) at Peripheral Gazes
Lens movement was evaluated by the investigator using a slit lamp with the eye in peripheral gaze (upward gaze, downward gaze, looking to the left, and looking to the right). Lens movement was assessed for each gaze on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). The overall lens fit grade was based on the worst-case scenario among the different gazes. A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Measured: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Proportion of Lenses Graded as Optimal Lens Centration or Acceptable Decentration at 6 Hour Follow-up in Lens Position (Centration)
Lens position was evaluated by the investigator using a slit lamp with the eye in primary position (relaxed, looking straight ahead). Lens position was graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable decentration; 2 = Unacceptable decentration. A grade of Optimal Centration or Acceptable Decentration is considered to be acceptable centration.
Measured: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start28 Apr 2025
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Principal Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884202
- Sponsor's protocol ID
- CLU484-P007
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2025
- Last updated
- 21 Aug 2026
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Overall Lens Fit of Delefilcon A Contact Lenses of Different Diameters and Base Curves
- ClinicalTrials.gov ID
- NCT06884202
- Acronym / sponsor ID
- CLU484-P007
- Conditions
- Refractive Errors, Myopia
- Keywords
- Contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Posted 21 Aug 2026
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 the study is to evaluate the lens fit characteristics of delefilcon A contact lenses with different base curves and diameters.
Detailed description
Subjects will be expected to attend 4 office visits for an individual duration of participation of approximately 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LID023681, then LID006961 | Other | Device: Delefilcon A contact lenses with different base curves and diameters, Device: Delefilcon A contact lenses with standard base curves and diametersDelefilcon A contact lenses with different base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with standard base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods. |
| LID006961, then LID023681 | Other | Device: Delefilcon A contact lenses with different base curves and diameters, Device: Delefilcon A contact lenses with standard base curves and diametersDelefilcon A contact lenses with standard base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with different base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and a minimum of 6 hours per day during the past 3 months;
- Able to wear contact lenses within a range of sphere powers from -2.00 and -4.00 diopters (D);
- Best Corrected Visual Acuity (BCVA) (with manifest refraction) better than or equal to 0.10 logarithm Minimum Angle of Resolution (logMAR ) in each eye.
Key exclusion criteria (4 listed)
- Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
- History of refractive surgery or plan to have refractive surgery during the study, or irregular cornea in either eye;
- Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates.
- Other protocol-defined inclusion/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 |
|---|---|---|
| Delefilcon A contact lenses with different base curves and diametersAlso: LID023681Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. | Device | LID006961, then LID023681, LID023681, then LID006961 |
| Delefilcon A contact lenses with standard base curves and diametersAlso: DAILIES TOTAL1®, LID006961Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. | Device | LID006961, then LID023681, LID023681, then LID006961 |
Primary outcome
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in Lens Movement (Overall Lens Fit) at Primary Gaze
Time frame: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Lens movement was evaluated by the investigator using a slit lamp with the eye in primary gaze (looking straight ahead). Subject was asked to blink after which the investigator pushed up the lower lid margin to evaluate lens movement. Lens movement was graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in Lens Movement (Overall Lens Fit) at Peripheral Gazes
Time frame: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Lens movement was evaluated by the investigator using a slit lamp with the eye in peripheral gaze (upward gaze, downward gaze, looking to the left, and looking to the right). Lens movement was assessed for each gaze on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). The overall lens fit grade was based on the worst-case scenario among the different gazes. A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Proportion of Lenses Graded as Optimal Lens Centration or Acceptable Decentration at Dispense in Lens Position (Centration)
Time frame: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period
Lens position was evaluated by the investigator using a slit lamp with the eye in primary position (relaxed, looking straight ahead). Lens position was graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable decentration; 2 = Unacceptable decentration. A grade of Optimal Centration or Acceptable Decentration is considered to be acceptable centration.
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in Lens Movement (Overall Fit) at Primary Gaze
Time frame: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Lens movement was evaluated by the investigator using a slit lamp with the eye in primary gaze (looking straight ahead). Subject was asked to blink after which the investigator pushed up the lower lid margin to evaluate lens movement. Lens movement was graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in Lens Movement (Overall Fit) at Peripheral Gazes
Time frame: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Lens movement was evaluated by the investigator using a slit lamp with the eye in peripheral gaze (upward gaze, downward gaze, looking to the left, and looking to the right). Lens movement was assessed for each gaze on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). The overall lens fit grade was based on the worst-case scenario among the different gazes. A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit.
Proportion of Lenses Graded as Optimal Lens Centration or Acceptable Decentration at 6 Hour Follow-up in Lens Position (Centration)
Time frame: Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period
Lens position was evaluated by the investigator using a slit lamp with the eye in primary position (relaxed, looking straight ahead). Lens position was graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable decentration; 2 = Unacceptable decentration. A grade of Optimal Centration or Acceptable Decentration is considered to be acceptable centration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- EducationalLink provided by the sponsor.
- 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.
Principal Clinical Trial Lead, Vision Care study director
Alcon Research, LLC
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delefilcon A contact lenses with different base curves and diameters and Delefilcon A contact lenses with standard base curves and diameters in people with Refractive Errors and Myopia, run by Alcon Research at 16 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 3 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 21 Aug 2026). 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?
Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in Lens Movement (Overall Lens Fit) at Primary Gaze (time frame: Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period). The study lists 6 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 21 Aug 2026.