Dry EyeT30DONCT06967298
Total30 For Contact Lens Dropouts
A study testing T30 Contact lenses in people with Dry Eye and Contact Lens Complication, run by Southern College of Optometry at 1 site in United States.
Trial summary
Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on CL discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance… 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, Contact Lenses
- What is being tested?
- T30 Contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2024to 28 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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- to 40-year-old, past CL wearers who have best corrected 20/20 visual acuity or better
- Participants will be required to have worn reusable CLs for at least one year in the past.
- Participants over the age of 40 years will be excluded to avoid presbyopia-related vision issues.
- Participants must have dropped out of reusable CLs within the past two years because of discomfort or dryness.
- This determination will be made by listing Young et al.'s list of reasons for dropping out of CLs and asking the participants to indicate their top reason for dropping out of CLs:
- Discomfort or Dryness b. General Poor Vision, c. Poor Reading Vision, d. Difficulty with Handling, e. Advised by Practitioner, f. Inconvenient, g. Eyes were Red, h. Lost Interest, i. Too Costly, j. Reaction to Care Products, k. Lost Lenses, l. Other.
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- . Participants will be considered a CL dropout if they have not worn CLs in the past 3 months. Participants will be required to have scores of ≤3 on the SPEED questionaries' (no significant dry eye symptoms).
- Participants will be required to be able to wear T30 sphere CLs (astigmatism ≤ 0.75 D OD/OS).
- Participants will be required to provide a prescription for glasses that is less than 3 years old.
Who cannot join
- if they are past rigid CL wearers,
- have worn reusable CLs within the past two years,
- have a history of being diagnosed with dry eye or ocular allergies,
- have known systemic health conditions that are thought to alter tear film physiology,
- have a history of viral eye disease,
- have a history of ocular surgery,
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- have a history of severe ocular trauma,
- have a history of corneal dystrophies or degenerations,
- have active ocular infection or inflammation,
- are currently using isotretinoin-derivatives or ocular medications, or
- if they are pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Southern College of Optometry
Memphis, Tennessee, 38104
About this study
Official title: How Does Total 30 Sphere Perform in Those Who Previously Dropped Out of Contact Lenses Due to Comfort or Dryness?
Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on 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."
Read the detailed description
Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on 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."1 While CL dropout occurs in about 20% of wearers annually the majority of CL wearers who cease wearing their CLs have a desire to continue wearing their CL if given the opportunity.3 A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs Therefore, providing CL dropouts with an alternative material, which may be more comfortable than their past CLs, could be a means for curbing CL dropout.
Our recent work found that when 60 participants who had previously dropped out of CLs were given the opportunity to be refit into Dailies TOTAL1® CLs that 100% of them were still wearing Dailies TOTAL1® at 1 month and 98% of them were still wearing their CLs at 6 months. When these participants were asked at the 1-month visit, 98.3%, 86.5%, and 93.2% of them responded that they were very satisfied or satisfied with their vision, their end-of-day CL comfort, and overall CL comfort, respectively. These same participants responded at 6 months that they were very likely or likely to continue to wear the study CLs (80.7%) and to recommend the study CLs to a friend (93.2%). While these data suggest that CL dropout can thrive when being refit into a daily disposable CLs, the literature currently lacks a targeted study aimed at understanding how CL dropouts will respond to being refit into a monthly replacement CL. One good potential monthly CL option is the TOTAL30® (T30) CL. T30 is a relatively new frequent replacement CL, with a biocompatible design. Thus, the purpose of this study is to determine the frequency that CL dropouts who dropped out of CLs because of dryness or discomfort can be comfortably refit into T30 CLs at 1 month.
- Conditions
- Dry Eye, Contact Lens Complication, Contact Lenses
- Being tested
- T30 Contact lenses
- 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.
T30 Contact lensesDevice
Individuals who have previously dropped out of Contact lenses (CL) due to discomfort will be refit into T30 contact lenses and their comfort with the product will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| T30 For Dropouts | Experimental | Total 30 contact lenses for those who have previously dropped out of CL wear Receives: Device: T30 Contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likelihood of continuing to wear T30 CLs at 1 month and 6 months
Participants will be refit into new contact lenses and their comfort will be asked about their comfort.In which a higher score is better.
Measured: 1 month and 6 months
Overall satisfaction while wearing T30 CLs at 1 month and 6 months.
Comfort in the lenses will be judged at 1 and 6 months to determine if the participant is satisfied using Visual Acuity scores in which higher scores are better.
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start23 Apr 2024
- Primary completion20 Nov 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This prospective 6 month 4 visit survey will refit individuals who have previously dropped out of contact lenses that is stopped wearing them due to discomfort into T30 contact lenses to determine if they are comfortable.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern College of Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967298
- Sponsor's protocol ID
- irb00006763
- Acronym
- T30DO
- Status last verified
- Nov 2025
- First submitted
- 21 Feb 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Total 30 Sphere Perform in Those Who Previously Dropped Out of Contact Lenses Due to Comfort or Dryness?
- ClinicalTrials.gov ID
- NCT06967298
- Acronym / sponsor ID
- T30DO / irb00006763
- Conditions
- Dry Eye, Contact Lens Complication, Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on 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."
Detailed description
Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on 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."1 While CL dropout occurs in about 20% of wearers annually the majority of CL wearers who cease wearing their CLs have a desire to continue wearing their CL if given the opportunity.3 A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs Therefore, providing CL dropouts with an alternative material, which may be more comfortable than their past CLs, could be a means for curbing CL dropout.
Our recent work found that when 60 participants who had previously dropped out of CLs were given the opportunity to be refit into Dailies TOTAL1® CLs that 100% of them were still wearing Dailies TOTAL1® at 1 month and 98% of them were still wearing their CLs at 6 months. When these participants were asked at the 1-month visit, 98.3%, 86.5%, and 93.2% of them responded that they were very satisfied or satisfied with their vision, their end-of-day CL comfort, and overall CL comfort, respectively. These same participants responded at 6 months that they were very likely or likely to continue to wear the study CLs (80.7%) and to recommend the study CLs to a friend (93.2%). While these data suggest that CL dropout can thrive when being refit into a daily disposable CLs, the literature currently lacks a targeted study aimed at understanding how CL dropouts will respond to being refit into a monthly replacement CL. One good potential monthly CL option is the TOTAL30® (T30) CL. T30 is a relatively new frequent replacement CL, with a biocompatible design. Thus, the purpose of this study is to determine the frequency that CL dropouts who dropped out of CLs because of dryness or discomfort can be comfortably refit into T30 CLs at 1 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 6 month 4 visit survey will refit individuals who have previously dropped out of contact lenses that is stopped wearing them due to discomfort into T30 contact lenses to determine if they are comfortable.
| Arm | Type | Receives |
|---|---|---|
| T30 For Dropouts | Experimental | Device: T30 Contact lensesTotal 30 contact lenses for those who have previously dropped out of CL wear |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adults, 18- to 40-year-old, past CL wearers who have best corrected 20/20 visual acuity or better
- Participants will be required to have worn reusable CLs for at least one year in the past.
- Participants over the age of 40 years will be excluded to avoid presbyopia-related vision issues.
- Participants must have dropped out of reusable CLs within the past two years because of discomfort or dryness.
- This determination will be made by listing Young et al.'s list of reasons for dropping out of CLs and asking the participants to indicate their top reason for dropping out of CLs:
Key exclusion criteria (11 listed)
- if they are past rigid CL wearers,
- have worn reusable CLs within the past two years,
- have a history of being diagnosed with dry eye or ocular allergies,
- have known systemic health conditions that are thought to alter tear film physiology,
- have a history of viral eye disease,
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 |
|---|---|---|
| T30 Contact lensesIndividuals who have previously dropped out of Contact lenses (CL) due to discomfort will be refit into T30 contact lenses and their comfort with the product will be assessed. | Device | T30 For Dropouts |
Primary outcome
Likelihood of continuing to wear T30 CLs at 1 month and 6 months
Time frame: 1 month and 6 months
Participants will be refit into new contact lenses and their comfort will be asked about their comfort.In which a higher score is better.
Overall satisfaction while wearing T30 CLs at 1 month and 6 months.
Time frame: 1-6 months
Comfort in the lenses will be judged at 1 and 6 months to determine if the participant is satisfied using Visual Acuity scores in which higher scores are better.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T30 Contact lenses in people with Dry Eye and Contact Lens Complication, run by Southern College of Optometry 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 9 inclusion and 11 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 3 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Likelihood of continuing to wear T30 CLs at 1 month and 6 months (time frame: 1 month and 6 months). The study lists 2 primary outcomes in all. 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 3 Dec 2025.