AstigmatismNCT05498649
Performance of Dailies Total1® Contact Lenses for Astigmatism in Symptomatic Habitual Reusable Toric Lens Wearers
An observational study of Astigmatism, run by Keith Wan at 1 site in United States.
Trial summary
To subjectively evaluate Dailies Total1® contact lenses for astigmatism (DT1fA) performance compared to other common weekly/monthly contact lenses in symptomatic patients. Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- Astigmatism
- What is being tested?
- DT1fA
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2022to 16 Dec 2022
- Phase
- Observational
- 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 to 38 years
- All sexes
- Adult
Study population: Eligible participants will be 18-38 years of age who are current and appropriate candidates for contact lens wear.
Who may be able to join
- Willing and able to provide informed consent
- Adult (18-38 years of age)
- Adapted and optimized current reusable soft toric lens wearer who has at least 3 months of wearing experience, and typically wears lenses every day, or at least 5 days per week, ≥10 hours per day
- Prescription needs with sphere and cylinder values that can be appropriately fit with current available parameters in the Dailies Total1® Contact lenses for Astigmatism product line
- Vision correctable to 20/25 Snellen (0.1 logMAR) or better in each eye at 6m
- Willing to wear lenses every day or at least 5 days per week, 10 or more hours per day and attend all study visits and follow instructions
- CLDEQ-8 minimum score of 12
Who cannot join
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Ocular anterior segment infection, inflammation, abnormality, or active disease including diagnosed dry eye, that would contraindicate contact lens wear
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator
- Monocular (only 1 eye with functional vision) or fit with only 1 lens
- Fitted with monovision
- Prior Refractive Surgery
Show all 10Show fewer
- History of herpetic keratitis, ocular surgery, or irregular cornea
- Pregnant or lactating
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Poway Eyecare & Optometry
San Diego, California, 92131
About this study
To subjectively evaluate Dailies Total1® contact lenses for astigmatism (DT1fA) performance compared to other common weekly/monthly contact lenses in symptomatic patients.
Read the detailed description
This study is a single site, prospective, subject-masked, observational study of the subjective performance of DT1fA in symptomatic patients. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include measurement of visual acuity, manifest refraction, and patient questionnaires.
- Conditions
- Astigmatism
- Being tested
- DT1fA
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT1fADevice
DT1fA contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Bilateral use of DT1fA contact lenses | DT1fA contact lenses Receives: Device: DT1fA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
A series of 8 questions that ask participants to rate eye discomfort, eye dryness, and blurry vision on a frequency scale (0 Never, 1 Rarely, 2 Sometimes, 3 Frequently, 4 Constantly) and an intensity scale (0 Never, 1 not intense to 5 Very Intense). Scores on individual questions are added together to determine a total score. Higher values indicate worse outcomes. The minimum score is 1 and the maximum score is 37.
Measured: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start2 Aug 2022
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
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 AstigmatismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keith Wan
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor-investigator, Keith Wan, Scripps Poway Eyecare and Optometry
- Investigators
- Keith Wan, OD, Principal investigator, Scripps Poway Eyecare & Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498649
- Sponsor's protocol ID
- KW-22-001
- Status last verified
- Sep 2024
- First submitted
- 10 Aug 2022
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Dailies Total1® Contact Lenses for Astigmatism in Symptomatic Habitual Reusable Toric Lens Wearers
- ClinicalTrials.gov ID
- NCT05498649
- Acronym / sponsor ID
- KW-22-001
- Conditions
- Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Keith WanUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To subjectively evaluate Dailies Total1® contact lenses for astigmatism (DT1fA) performance compared to other common weekly/monthly contact lenses in symptomatic patients.
Detailed description
This study is a single site, prospective, subject-masked, observational study of the subjective performance of DT1fA in symptomatic patients. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include measurement of visual acuity, manifest refraction, and patient questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral use of DT1fA contact lenses | – | Device: DT1fADT1fA contact lenses |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Age groups
- Adult
- Study population
- Eligible participants will be 18-38 years of age who are current and appropriate candidates for contact lens wear.
Key inclusion criteria (7 listed)
- Willing and able to provide informed consent
- Adult (18-38 years of age)
- Adapted and optimized current reusable soft toric lens wearer who has at least 3 months of wearing experience, and typically wears lenses every day, or at least 5 days per week, ≥10 hours per day
- Prescription needs with sphere and cylinder values that can be appropriately fit with current available parameters in the Dailies Total1® Contact lenses for Astigmatism product line
- Vision correctable to 20/25 Snellen (0.1 logMAR) or better in each eye at 6m
Key exclusion criteria (10 listed)
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Ocular anterior segment infection, inflammation, abnormality, or active disease including diagnosed dry eye, that would contraindicate contact lens wear
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator
- Monocular (only 1 eye with functional vision) or fit with only 1 lens
- Fitted with monovision
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 |
|---|---|---|
| DT1fADT1fA contact lenses | Device | Bilateral use of DT1fA contact lenses |
Primary outcome
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
Time frame: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)
A series of 8 questions that ask participants to rate eye discomfort, eye dryness, and blurry vision on a frequency scale (0 Never, 1 Rarely, 2 Sometimes, 3 Frequently, 4 Constantly) and an intensity scale (0 Never, 1 not intense to 5 Very Intense). Scores on individual questions are added together to determine a total score. Higher values indicate worse outcomes. The minimum score is 1 and the maximum score is 37.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Keith Wan, OD principal investigator
Scripps Poway Eyecare & Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Astigmatism, run by Keith Wan at 1 site 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 7 inclusion and 10 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 19 Sep 2024). 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?
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score (time frame: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)). 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 Sep 2024.