AstigmatismNCT05805345
Clinical Comparison of Toric Contact Lenses Fit Characteristics
A study testing Delefilcon A toric soft contact lens, Lehfilcon A toric soft contact lens and Lotrafilcon B toric soft contact lens in people with Astigmatism and Refractive Errors, run by Alcon Research at 7 sites in United States.
Trial summary
The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism, Refractive Errors
- What is being tested?
- Delefilcon A toric soft contact lens, Lehfilcon A toric soft contact lens and Lotrafilcon B toric soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2023to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability).
- Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye.
- Willing to stop wearing habitual contact lenses during in-office visits.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Current spherical, monovision or multifocal lens wearer.
- Protocol-specified biomicroscopy findings at screening.
- Current or history of herpetic keratitis in either eye.
- Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
ProCare Vision Centers, Inc.
Granville, Ohio, 43023
Omega Vision Center P.A.
Longwood, Florida, 32779
Kurata Eyecare Center
Los Angeles, California, 90013
Kindred Optics at Maitland Vision
Maitland, Florida, 32751
Optometry Group, PLLC
Memphis, Tennessee, 38111
Kannarr Eye Care LLC
Pittsburg, Kansas, 66762
Clarke EyeCare Center
Wichita Falls, Texas, 76308
About this study
The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.
Read the detailed description
Subjects will be expected to attend 3 visits including the screening visit. The total duration of a subject's participation in the study will be approximately 19 days.
- Conditions
- Astigmatism, Refractive Errors
- Being tested
- Delefilcon A toric soft contact lens, Lehfilcon A toric soft contact lens, Lotrafilcon B toric soft contact lens, Verofilcon A toric soft contact lens
- Keywords
- Contact Lenses
- Medical subject headings
- Astigmatism, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delefilcon A toric soft contact lensDevice
Also called DT1fA, DAILIES TOTAL1® for Astigmatism
Commercially available silicone hydrogel contact lens
Lehfilcon A toric soft contact lensDevice
Also called T30fA, TOTAL30™ for Astigmatism
Commercially available silicone hydrogel contact lens
Lotrafilcon B toric soft contact lensDevice
Also called AOHGfA, AIR OPTIX® plus HydraGlyde® for Astigmatism
Commercially available silicone hydrogel contact lens
Verofilcon A toric soft contact lensDevice
Also called P1fA, PRECISION1® for Astigmatism
Commercially available silicone hydrogel contact lens
| Study group | Role | What they receive |
|---|---|---|
| DT1fA/T30fA/AOHGfA/P1fA | Other | DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. Receives: Device: Delefilcon A toric soft contact lens; Device: Lehfilcon A toric soft contact lens; Device: Lotrafilcon B toric soft contact lens; Device: Verofilcon A toric soft contact lens |
| T30fA/AOHGfA/P1fA/DT1fA | Other | T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. Receives: Device: Delefilcon A toric soft contact lens; Device: Lehfilcon A toric soft contact lens; Device: Lotrafilcon B toric soft contact lens; Device: Verofilcon A toric soft contact lens |
| AOHGfA/P1fA/DT1fA/T30fA | Other | AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. Receives: Device: Delefilcon A toric soft contact lens; Device: Lehfilcon A toric soft contact lens; Device: Lotrafilcon B toric soft contact lens; Device: Verofilcon A toric soft contact lens |
| P1fA/DT1fA/T30fA/AOHGfA | Other | P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. Receives: Device: Delefilcon A toric soft contact lens; Device: Lehfilcon A toric soft contact lens; Device: Lotrafilcon B toric soft contact lens; Device: Verofilcon A toric soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance VA with study lenses
Visual Acuity (VA) will be assessed using letter charts with study lenses in place and reported in logarithm minimum angle of resolution (logMAR). A logMAR value of 0.0 equates to 20/20 Snellen, which is considered normal distance eyesight. Eyes will be assessed individually.
Measured: 30 mins (± 15 mins), each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Management Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies 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
- 0 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 chair, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805345
- Sponsor's protocol ID
- CLF993-P001
- Status last verified
- May 2023
- First submitted
- 23 Mar 2023
- Last updated
- 19 May 2023
- Results posted
- No
- 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 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Toric Contact Lenses Fit Characteristics
- ClinicalTrials.gov ID
- NCT05805345
- Acronym / sponsor ID
- CLF993-P001
- Conditions
- Astigmatism, Refractive Errors
- Keywords
- Contact Lenses
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Management Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
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 compare the fit characteristics between four Alcon commercially available toric contact lenses.
Detailed description
Subjects will be expected to attend 3 visits including the screening visit. The total duration of a subject's participation in the study will be approximately 19 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DT1fA/T30fA/AOHGfA/P1fA | Other | Device: Delefilcon A toric soft contact lens, Device: Lehfilcon A toric soft contact lens, Device: Lotrafilcon B toric soft contact lens, Device: Verofilcon A toric soft contact lensDT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. |
| T30fA/AOHGfA/P1fA/DT1fA | Other | Device: Delefilcon A toric soft contact lens, Device: Lehfilcon A toric soft contact lens, Device: Lotrafilcon B toric soft contact lens, Device: Verofilcon A toric soft contact lensT30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. |
| AOHGfA/P1fA/DT1fA/T30fA | Other | Device: Delefilcon A toric soft contact lens, Device: Lehfilcon A toric soft contact lens, Device: Lotrafilcon B toric soft contact lens, Device: Verofilcon A toric soft contact lensAOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. |
| P1fA/DT1fA/T30fA/AOHGfA | Other | Device: Delefilcon A toric soft contact lens, Device: Lehfilcon A toric soft contact lens, Device: Lotrafilcon B toric soft contact lens, Device: Verofilcon A toric soft contact lensP1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability).
- Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye.
- Willing to stop wearing habitual contact lenses during in-office visits.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Current spherical, monovision or multifocal lens wearer.
- Protocol-specified biomicroscopy findings at screening.
- Current or history of herpetic keratitis in either eye.
- Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- Other protocol-defined 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 toric soft contact lensAlso: DT1fA, DAILIES TOTAL1® for AstigmatismCommercially available silicone hydrogel contact lens | Device | AOHGfA/P1fA/DT1fA/T30fA, DT1fA/T30fA/AOHGfA/P1fA, P1fA/DT1fA/T30fA/AOHGfA, T30fA/AOHGfA/P1fA/DT1fA |
| Lehfilcon A toric soft contact lensAlso: T30fA, TOTAL30™ for AstigmatismCommercially available silicone hydrogel contact lens | Device | AOHGfA/P1fA/DT1fA/T30fA, DT1fA/T30fA/AOHGfA/P1fA, P1fA/DT1fA/T30fA/AOHGfA, T30fA/AOHGfA/P1fA/DT1fA |
| Lotrafilcon B toric soft contact lensAlso: AOHGfA, AIR OPTIX® plus HydraGlyde® for AstigmatismCommercially available silicone hydrogel contact lens | Device | AOHGfA/P1fA/DT1fA/T30fA, DT1fA/T30fA/AOHGfA/P1fA, P1fA/DT1fA/T30fA/AOHGfA, T30fA/AOHGfA/P1fA/DT1fA |
| Verofilcon A toric soft contact lensAlso: P1fA, PRECISION1® for AstigmatismCommercially available silicone hydrogel contact lens | Device | AOHGfA/P1fA/DT1fA/T30fA, DT1fA/T30fA/AOHGfA/P1fA, P1fA/DT1fA/T30fA/AOHGfA, T30fA/AOHGfA/P1fA/DT1fA |
Primary outcome
Distance VA with study lenses
Time frame: 30 mins (± 15 mins), each product
Visual Acuity (VA) will be assessed using letter charts with study lenses in place and reported in logarithm minimum angle of resolution (logMAR). A logMAR value of 0.0 equates to 20/20 Snellen, which is considered normal distance eyesight. Eyes will be assessed individually.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- 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 chair
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 Delefilcon A toric soft contact lens, Lehfilcon A toric soft contact lens and Lotrafilcon B toric soft contact lens in people with Astigmatism and Refractive Errors, 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 19 May 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 VA with study lenses (time frame: 30 mins (± 15 mins), each product). 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 19 May 2023.