Dry EyeNCT05239494
Dailies Total 1 Sphere Contact Lenses
A study testing DT1 Sphere Contact Lenses in people with Dry Eye and Contact Lens Complication, run by University of Alabama at Birmingham at 4 sites in United States.
Trial summary
CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society in their seminal report on contact lens (CL) discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Contact Lens Complication
- What is being tested?
- DT1 Sphere Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 May 2022to 30 Aug 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18-40
- Past contact lens wearers who have best corrected 20/20 visual acuity or better
- Participants will have had to have worn contact lenses for at least 1 year in the past
- Dropped out of contact lenses in the past 2 years do to discomfort or dryness
- Scores of 3 or less on the SPEED questionnaire
- Be able to be refit into Dailies Total1 Sphere contact lenses
- Provide a glasses prescription that is less than 3-years-old
Who cannot join
- Past rigid contact lens wearers
- A past history of being diagnosed with dry eye or ocular allergies
- Known systemic health conditions that are known to alter tear film physiology
- History of viral eye disease
- History of ocular surgery
- History of severe ocular trauma
Show all 10Show fewer
- History of corneal dystrophies or degeneration
- Having active ocular infection or inflammation
- Currently using isotretinoin-derivatives or ocular medication
- Pregnant or breast feeding
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35213
ProCare Vision Center
Granville, Ohio, 43023
The Southern College of Optometry
Memphis, Tennessee, 38104
Kannarr Eye Care
Pittsburg, Kansas, 66762
About this study
Official title: How Does DT1 Sphere Perform in Those Who Previously Dropped Out of Contact Lenses Due to Comfort or Dryness?
CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society in their seminal report on contact lens (CL) discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear." A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs. This same review alarmingly found that the frequency of CL dropout was about 20% across the many studies aimed at evaluating this condition, which is surprising given the introduction of better soft CL materials and daily disposable CLs over the past 20 plus years.
Dailies Total1 (DT1), which is a relatively new daily disposable CL, is a commonly used trouble shooting CL for patients who have failed with other CLs because DT1 utilizes advanced material technology that is specifically aimed at improving CL comfort. While DT1 is commonly used in these struggling patients, the literature currently lacks a targeted study aimed at understanding the frequency of successfully refitting CL dropouts into this advanced CL. Thus, the purpose of this study is to determine the frequency that past CL wearers who failed because of dryness or CL discomfort who can comfortable wear DT1.
- Conditions
- Dry Eye, Contact Lens Complication
- Being tested
- DT1 Sphere Contact Lenses
- Keywords
- Contact Lens, Dailies Total1, Dry Eye, Comfort
- 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.
DT1 Sphere Contact LensesDevice
Devices: Dailies Total 1 Sphere Contact Lenses
| Study group | Role | What they receive |
|---|---|---|
| Dailies Total1 | Experimental | All participants will be asked to wear Dailies Total1 for the duration of this study. Receives: Device: DT1 Sphere Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Contact Lenses Comfort Scores
The median visual analog scale (VAS) scores at the 1-month visit (-50 to +50 scale with scores greater than 0 being comfortable).
Measured: 1 month
Secondary outcomes (1)
Likert Questionnaire
Number of participants who were likely to refer the study contact lens to a friend.
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start23 May 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
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 Dry EyeStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be assigned to wear Dailies Total 1 Sphere contact lenses. They will report to 3 in person visits over the course of one month.
- Masking
- None (open label)
- Enrolment
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239494
- Sponsor's protocol ID
- IRB-300008359
- Status last verified
- Sep 2024
- First submitted
- 4 Feb 2022
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does DT1 Sphere Perform in Those Who Previously Dropped Out of Contact Lenses Due to Comfort or Dryness?
- ClinicalTrials.gov ID
- NCT05239494
- Acronym / sponsor ID
- IRB-300008359
- Conditions
- Dry Eye, Contact Lens Complication
- Keywords
- Contact Lens, Dailies Total1, Dry Eye, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 23 May 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 15 Feb 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.
CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society in their seminal report on contact lens (CL) discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear." A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs. This same review alarmingly found that the frequency of CL dropout was about 20% across the many studies aimed at evaluating this condition, which is surprising given the introduction of better soft CL materials and daily disposable CLs over the past 20 plus years.
Dailies Total1 (DT1), which is a relatively new daily disposable CL, is a commonly used trouble shooting CL for patients who have failed with other CLs because DT1 utilizes advanced material technology that is specifically aimed at improving CL comfort. While DT1 is commonly used in these struggling patients, the literature currently lacks a targeted study aimed at understanding the frequency of successfully refitting CL dropouts into this advanced CL. Thus, the purpose of this study is to determine the frequency that past CL wearers who failed because of dryness or CL discomfort who can comfortable wear DT1.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be assigned to wear Dailies Total 1 Sphere contact lenses. They will report to 3 in person visits over the course of one month.
| Arm | Type | Receives |
|---|---|---|
| Dailies Total1 | Experimental | Device: DT1 Sphere Contact LensesAll participants will be asked to wear Dailies Total1 for the duration of this study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults 18-40
- Past contact lens wearers who have best corrected 20/20 visual acuity or better
- Participants will have had to have worn contact lenses for at least 1 year in the past
- Dropped out of contact lenses in the past 2 years do to discomfort or dryness
- Scores of 3 or less on the SPEED questionnaire
Key exclusion criteria (10 listed)
- Past rigid contact lens wearers
- A past history of being diagnosed with dry eye or ocular allergies
- Known systemic health conditions that are known to alter tear film physiology
- History of viral eye disease
- History of ocular surgery
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 Sphere Contact LensesDevices: Dailies Total 1 Sphere Contact Lenses | Device | Dailies Total1 |
Primary outcome
Visual Analog Scale (VAS) Contact Lenses Comfort Scores
Time frame: 1 month
The median visual analog scale (VAS) scores at the 1-month visit (-50 to +50 scale with scores greater than 0 being comfortable).
1 secondary outcome
Likert Questionnaire
Time frame: One Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DT1 Sphere Contact Lenses in people with Dry Eye and Contact Lens Complication, run by University of Alabama at Birmingham at 4 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 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
Visual Analog Scale (VAS) Contact Lenses Comfort Scores (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 1 Oct 2024.