Refractive ErrorsNCT03762668
Performance Assessment of a Modified Daily Disposable Contact Lens
A study testing Modified delefilcon A contact lenses and Delefilcon A contact lenses in people with Refractive Errors and Myopia, run by Alcon Research at 5 sites in United States.
Trial summary
The purpose of this study is to compare visual acuity between two daily disposable contact lenses. 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?
- Modified delefilcon A contact lenses and Delefilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Dec 2018to 7 Jan 2019
- 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 approved Informed Consent form;
- Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
- Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
- Monocular (only one eye with functional vision);
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Alcon Investigative Site
Ann Arbor, Michigan, 48105
Alcon Investigative Site
Maitland, Florida, 32751
Alcon Investigative Site
Memphis, Tennessee, 38111
Alcon Investigative Site
Orlando, Florida, 32803
Alcon Investigative Site
West Palm Beach, Florida, 33405
About this study
The purpose of this study is to compare visual acuity between two daily disposable contact lenses.
Read the detailed description
The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.
- Conditions
- Refractive Errors, Myopia, Hyperopia
- Being tested
- Modified delefilcon A contact lenses, Delefilcon A contact lenses
- Keywords
- Contact lens, Vision correction, Visual acuity
- 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.
Modified delefilcon A contact lensesDevice
Also called MDACL
Spherical soft daily disposable contact lens
Delefilcon A contact lensesDevice
Also called DACL
Spherical soft daily disposable contact lens
| Study group | Role | What they receive |
|---|---|---|
| MDACL, then DACL | Other | Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality. Receives: Device: Modified delefilcon A contact lenses; Device: Delefilcon A contact lenses |
| DACL, then MDACL | Other | DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality. Receives: Device: Modified delefilcon A contact lenses; Device: Delefilcon A contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Contrast Distance Visual Acuity (logMAR)
Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.
Measured: Day 1 Dispense, Day 7 Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start3 Dec 2018
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. CDMA Project Lead, Vision Care, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762668
- Sponsor's protocol ID
- CLP691-C002
- Status last verified
- Jan 2020
- First submitted
- 1 Dec 2018
- Last updated
- 13 Jan 2020
- 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 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of a Modified Daily Disposable Contact Lens
- ClinicalTrials.gov ID
- NCT03762668
- Acronym / sponsor ID
- CLP691-C002
- Conditions
- Refractive Errors, Myopia, Hyperopia
- Keywords
- Contact lens, Vision correction, Visual acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Posted 7 Jan 2020
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 visual acuity between two daily disposable contact lenses.
Detailed description
The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDACL, then DACL | Other | Device: Modified delefilcon A contact lenses, Device: Delefilcon A contact lensesModified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality. |
| DACL, then MDACL | Other | Device: Modified delefilcon A contact lenses, Device: Delefilcon A contact lensesDACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to understand and sign an approved Informed Consent form;
- Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
- Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
- Monocular (only one eye with functional vision);
- 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 |
|---|---|---|
| Modified delefilcon A contact lensesAlso: MDACLSpherical soft daily disposable contact lens | Device | DACL, then MDACL, MDACL, then DACL |
| Delefilcon A contact lensesAlso: DACLSpherical soft daily disposable contact lens | Device | DACL, then MDACL, MDACL, then DACL |
Primary outcome
High Contrast Distance Visual Acuity (logMAR)
Time frame: Day 1 Dispense, Day 7 Follow-Up
Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- 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.
Sr. CDMA Project Lead, Vision Care study director
Alcon Research
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified delefilcon A contact lenses and Delefilcon A contact lenses in people with Refractive Errors and Myopia, run by Alcon Research at 5 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 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 7 Jan 2020). 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?
High Contrast Distance Visual Acuity (logMAR) (time frame: Day 1 Dispense, Day 7 Follow-Up). 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 Jan 2020.