Refractive ErrorsNCT04254003
Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
A study testing DT1 Toric contact lenses and AO1DfA contact lenses in people with Refractive Errors, run by Alcon Research at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors
- What is being tested?
- DT1 Toric contact lenses and AO1DfA contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Feb 2020to 2 Mar 2020
- 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
- Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
- Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
- Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
- Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any anterior segment 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 refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.
- Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Alcon Investigative Site CT-27
Eden Prairie, Minnesota, 55344
Alcon Investigative Site CT-11
Maitland, Florida, 32751
About this study
The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.
Read the detailed description
This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.
- Conditions
- Refractive Errors
- Being tested
- DT1 Toric contact lenses, AO1DfA contact lenses
- Keywords
- toric contact lens, daily disposable, silicone hydrogel contact lens, axis orientation, astigmatism
- Medical subject headings
- Refractive Errors, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT1 Toric contact lensesDevice
Also called Test, DAILIES TOTAL1 for Astigmatism (DT1 Toric)
Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)
AO1DfA contact lensesDevice
Also called Control, Acuvue Oasys 1-Day for Astigmatism (AO1DfA)
Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)
| Study group | Role | What they receive |
|---|---|---|
| Test, then Control | Other | DT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour. Receives: Device: DT1 Toric contact lenses; Device: AO1DfA contact lenses |
| Control, then Test | Other | AO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour. Receives: Device: DT1 Toric contact lenses; Device: AO1DfA contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion
A slit lamp will be used to observe axis orientation.
Measured: Day 1, 10 minutes after lens insertion, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start5 Feb 2020
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 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
- NCT04254003
- Sponsor's protocol ID
- CLO870-C003
- Status last verified
- Mar 2020
- First submitted
- 31 Jan 2020
- Last updated
- 18 Mar 2020
- 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT04254003
- Acronym / sponsor ID
- CLO870-C003
- Conditions
- Refractive Errors
- Keywords
- toric contact lens, daily disposable, silicone hydrogel contact lens, axis orientation, astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 5 Feb 2020 (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 evaluate the rotational behavior of DT1 Toric contact lenses.
Detailed description
This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test, then Control | Other | Device: DT1 Toric contact lenses, Device: AO1DfA contact lensesDT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour. |
| Control, then Test | Other | Device: DT1 Toric contact lenses, Device: AO1DfA contact lensesAO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
- Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
- Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
- Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Any anterior segment 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 refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.
- Eye injury in either eye within 12 weeks immediately prior to enrollment for this 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 |
|---|---|---|
| DT1 Toric contact lensesAlso: Test, DAILIES TOTAL1 for Astigmatism (DT1 Toric)Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia) | Device | Control, then Test, Test, then Control |
| AO1DfA contact lensesAlso: Control, Acuvue Oasys 1-Day for Astigmatism (AO1DfA)Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia) | Device | Control, then Test, Test, then Control |
Primary outcome
Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion
Time frame: Day 1, 10 minutes after lens insertion, each product
A slit lamp will be used to observe axis orientation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DT1 Toric contact lenses and AO1DfA contact lenses in people with Refractive Errors, run by Alcon Research at 2 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 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: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion (time frame: Day 1, 10 minutes after lens insertion, 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 18 Mar 2020.