AstigmatismNCT05886452
Success of Dailies Total1 for Astigmatism Contact Lenses in Patients That Have Previously Failed With Toric Contact Lenses
An observational study of Astigmatism, run by Mann Eye Institute at 1 site in United States.
Trial summary
The objective is to determine the percentages of past toric CL wearers (who dropped out of contact lens wear due to dissatisfaction with comfort or vision) who are satisfied with the comfort and vision of DT1fA contact lenses. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Astigmatism
- What is being tested?
- DT1fA contact lenses
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 Apr 2024
- 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 39 years
- All sexes
- Adult
Study population: Eligible test subjects will be 18 to 39 years of age with history of previous unsuccessful astigmatism contact lens wear.
Who may be able to join
- Subjects are eligible for the study if they meet the following criteria:
- Note: Ocular criteria must be met in both eyes.
- Gender: Males and Females.
- Subjects will be 18-39 years old.
- History of previous unsuccessful astigmatism contact lens wearer with qualifying answer to screening questions:
- I used to wear astigmatism correcting (toric) soft contact lenses.
Show all 15Show fewer
- (YES)
- I stopped wearing my previous astigmatism correcting soft contact lenses because of one or more of the below reasons:
- Poor or fluctuating vision
- Discomfort
- Other
- Subjects must have 20/25 or better distance visual acuity in each eye with current best correction.
- Good general health (defined by prescription medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
- Ability to give informed consent.
- Willing and able to spend time for the study (Subjects will be required to attend three study visits and wear contact lenses on days between study visits).
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.
- Previous ocular surgery.
- Inability to be fit with the DT1fA lens design.
- Subjects that should be wearing a toric contact lens for best acuity but have chosen to continue in spherical contact lens wear.
- History of Accutane use.
- Ocular surface disease that in the investigator's opinion would interfere with contact lens wear.
Show all 14Show fewer
- History of comorbidities, including autoimmune disorders and diabetes.
- Irregular astigmatism as identified by Pentacam.
- History of Amblyopia.
- History of Strabismus and/or history of eye muscle surgery.
- History of Monovision.
- Potential subjects who are pregnant.
- 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.
About this study
The objective is to determine the percentages of past toric CL wearers (who dropped out of contact lens wear due to dissatisfaction with comfort or vision) who are satisfied with the comfort and vision of DT1fA contact lenses.
Read the detailed description
This is a single arm, prospective, non-comparative, open-label post market clinical study of satisfaction of past toric CL wearers, with DT1fA contact lenses. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include measurement of visual acuity, manifest refraction, and administration a questionnaire
- Conditions
- Astigmatism
- Being tested
- DT1fA contact lenses
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT1fA contact lensesDevice
Subjects will be fitted with DT1fA contact lenses
| Study group | Role | What they receive |
|---|---|---|
| DT1fA contact lenses | Subjects fitted with DT1fA contact lenses Receives: Device: DT1fA contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Positive Ratings (>50 Out of 100) for Satisfaction of Comfort and Vision.
A questionnaire will be administered. Subjects are asked to rate their satisfaction with comfort and vision on a scale of 0 to 100, with higher ratings indicating higher satisfaction with comfort and vision.
Measured: After 30 days of DT1fA contact lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Aug 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mann Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Phillip Brunson, OD, Principal investigator, Mann Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886452
- Sponsor's protocol ID
- PB-23-02
- Status last verified
- Mar 2025
- First submitted
- 23 May 2023
- Last updated
- 25 Mar 2025
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success of Dailies Total1 for Astigmatism Contact Lenses in Patients That Have Previously Failed With Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT05886452
- Acronym / sponsor ID
- PB-23-02
- Conditions
- Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mann Eye InstituteUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to determine the percentages of past toric CL wearers (who dropped out of contact lens wear due to dissatisfaction with comfort or vision) who are satisfied with the comfort and vision of DT1fA contact lenses.
Detailed description
This is a single arm, prospective, non-comparative, open-label post market clinical study of satisfaction of past toric CL wearers, with DT1fA contact lenses. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include measurement of visual acuity, manifest refraction, and administration a questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DT1fA contact lenses | – | Device: DT1fA contact lensesSubjects fitted with DT1fA contact lenses |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Age groups
- Adult
- Study population
- Eligible test subjects will be 18 to 39 years of age with history of previous unsuccessful astigmatism contact lens wear.
Key inclusion criteria (15 listed)
- Note: Ocular criteria must be met in both eyes.
- Gender: Males and Females.
- Subjects will be 18-39 years old.
- History of previous unsuccessful astigmatism contact lens wearer with qualifying answer to screening questions:
- Subjects must have 20/25 or better distance visual acuity in each eye with current best correction.
Key exclusion criteria (14 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.
- Previous ocular surgery.
- Inability to be fit with the DT1fA lens design.
- Subjects that should be wearing a toric contact lens for best acuity but have chosen to continue in spherical contact lens wear.
- History of Accutane use.
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 |
|---|---|---|
| DT1fA contact lensesSubjects will be fitted with DT1fA contact lenses | Device | DT1fA contact lenses |
Primary outcome
Percentage of Patients With Positive Ratings (>50 Out of 100) for Satisfaction of Comfort and Vision.
Time frame: After 30 days of DT1fA contact lens wear
A questionnaire will be administered. Subjects are asked to rate their satisfaction with comfort and vision on a scale of 0 to 100, with higher ratings indicating higher satisfaction with comfort and vision.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
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.
Phillip Brunson, OD principal investigator
Mann Eye Institute
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 Mann Eye Institute 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 15 inclusion and 14 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 25 Mar 2025. 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 25 Mar 2025). 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?
Percentage of Patients With Positive Ratings (>50 Out of 100) for Satisfaction of Comfort and Vision. (time frame: After 30 days of DT1fA contact lens wear). 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 25 Mar 2025.