Contact Lens ComplicationNCT05183022
Total30 Sphere Contact Lenses
A study testing Total30 Sphere Contact Lenses in people with Contact Lens Complication and Dry Eye, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
The purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Complication, Dry Eye
- What is being tested?
- Total30 Sphere 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
- 3 Jan 2022to 20 Jul 2022
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current contact lens wearers who have 20/20 visual acuity or better
- Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (≤10)
- Astigmatism better than or equal to 0.50 D in each eye
- Must have regularly worn 2 week or monthly contact lenses within the past 6 months
- Must provide a glasses prescription that is is less than 3 years old
- Willing to start wearing their contact lenses between 6:00 AM and 8:00 AM and wear their contact lenses until 11:00 PM each day
Who cannot join
- Past or Current hard CL use
- Any known systemic health conditions that are thought to alter tear film physiology
- History of viral eye disease
- History of ocular surgery
- History of severe ocular trauma
- Active ocular infection or inflammation
Show all 10Show fewer
- Currently using isotretinoin-derivatives
- Currently using ocular medications
- Currently using rewetting drops or artificial tear
- Pregnant or breast feeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35213
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Do Total 30 Sphere Contact Lenses Provide a Comfortable Wearing Experience All Day?
The purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.
Read the detailed description
Contact lens (CL) wearers frequently face eye discomfort symptoms, especially towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 Sphere CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs. These data are not only important for judging the performance of Total30 Sphere CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.
- Conditions
- Contact Lens Complication, Dry Eye
- Being tested
- Total30 Sphere Contact Lenses
- Keywords
- Total30 Sphere Contact Lenses; Comfort; Dryness; Visual Analog Scale Scores
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total30 Sphere Contact LensesDevice
Also called Lehfilcon A
Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Total30 Sphere Contact Lenses | Experimental | All qualified participants will be refit into Total30 Sphere contact lenses. Receives: Device: Total30 Sphere Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Ocular Comfort
A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start3 Jan 2022
- Primary completion20 Jul 2022
- Study completion20 Jul 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 Contact Lens ComplicationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This prospective, one-month, three-visit study will refit all participants into Total30 Sphere contact lenses.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Andrew Pucker, University of Alabama at Birmingham
- Investigators
- Andrew D Pucker, OD, MS, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183022
- Sponsor's protocol ID
- IRB-300008004
- Status last verified
- Nov 2022
- First submitted
- 20 Dec 2021
- Last updated
- 16 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Total 30 Sphere Contact Lenses Provide a Comfortable Wearing Experience All Day?
- ClinicalTrials.gov ID
- NCT05183022
- Acronym / sponsor ID
- IRB-300008004
- Conditions
- Contact Lens Complication, Dry Eye
- Keywords
- Total30 Sphere Contact Lenses; Comfort; Dryness; Visual Analog Scale Scores
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Posted 16 Dec 2022
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 map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.
Detailed description
Contact lens (CL) wearers frequently face eye discomfort symptoms, especially towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 Sphere CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs. These data are not only important for judging the performance of Total30 Sphere CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This prospective, one-month, three-visit study will refit all participants into Total30 Sphere contact lenses.
| Arm | Type | Receives |
|---|---|---|
| Total30 Sphere Contact Lenses | Experimental | Device: Total30 Sphere Contact LensesAll qualified participants will be refit into Total30 Sphere contact lenses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Current contact lens wearers who have 20/20 visual acuity or better
- Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (≤10)
- Astigmatism better than or equal to 0.50 D in each eye
- Must have regularly worn 2 week or monthly contact lenses within the past 6 months
- Must provide a glasses prescription that is is less than 3 years old
Key exclusion criteria (10 listed)
- Past or Current hard CL use
- Any known systemic health conditions that are thought to alter tear film physiology
- History of viral eye disease
- History of ocular surgery
- History of severe ocular trauma
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 |
|---|---|---|
| Total30 Sphere Contact LensesAlso: Lehfilcon AParticipants will be refit into Total30 Sphere contact lenses and followed for 1 month. | Device | Total30 Sphere Contact Lenses |
Primary outcome
Visual Analog Scale (VAS) Ocular Comfort
Time frame: 1 month
A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Andrew D Pucker, OD, MS, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total30 Sphere Contact Lenses in people with Contact Lens Complication and Dry Eye, run by University of Alabama at Birmingham 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 6 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 16 Dec 2022. 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?
Yes. Results are posted in the registry (first posted 16 Dec 2022). 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?
Visual Analog Scale (VAS) Ocular Comfort (time frame: 1 month). 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 16 Dec 2022.