EyeNCT07914959
P1 Toric Vs. Max 1day
A study testing , silicone hydrogel (lehfilcon A) soft contact lens (CL) with SMARTSURFACE Technology and UV protection in people with Eye and Astigmatism, run by Southern College of Optometry at 1 site in United States.
Trial summary
This study aims to determine if participants who are currently wearing Max1day contact lenses can successfully be refit into P1 for astigmatism contact lenses. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Eye, Astigmatism, Contact Lenses
- What is being tested?
- , silicone hydrogel (lehfilcon A) soft contact lens (CL) with SMARTSURFACE Technology and UV protection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Adults, 18- to 40-year-old, current CL wearers who have best corrected 20/20 visual acuity or better
- Participants will be required to have worn MAX 1-Day for ASTIGMATISM CLs for at least 3 months in the past year and be currently wearing these CLs.
- All participants will be required to have a CLDEQ-8 score <12 while wearing their habitual CLs.
- Participants will be required to be able to wear P1 for Astigmatism and MAX 1-Day for ASTIGMATISM (astigmatism ≥0.75D OD/OS).
- Astigmatism ranging from 0.75 D to 2.50 D in each eye.
- Participants will be required to wear the study CLs for ≥12 hours each day with no overnight wear.
- Participants will be willing to wear the CL every day of the week.
- Participants will be required to provide a glasses prescription that is less than 3 years old.
Who cannot join
- Are past rigid CL wearers.
- 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.
- Have a history of severe ocular trauma.
Show all 10Show fewer
- Have a history of corneal dystrophies or degenerations.
- Have active ocular infection or inflammation.
- Are currently using isotretinoin-derivatives or ocular medications.
- 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: Clinical Performance of Verofilcon A Toric Contact Lenses in Satisfied Wearers of Senofilcon A Toric Contact Lenses With Blue Light Filtration
This study aims to determine if participants who are currently wearing Max1day contact lenses can successfully be refit into P1 for astigmatism contact lenses.
Read the detailed description
This one month 4 visit study will determine if participants who are current Max1day contact lens wearers are able to be refit into P1 for astigmatism contact lenses. P1 Toric contact lenses are designed to promote stable Toric axis during wear. This stands to benefit daily disposable contact lens wearers who have astigmatism. Because this technology is relatively new there is currently a lack of literature regarding comfortability and wear during the day. Therefore, this study aims to determine if current wearers of Max 1day contact lenses can be refit into the new P1 Toric contact lenses.
- Conditions
- Eye, Astigmatism, Contact Lenses
- Being tested
- , silicone hydrogel (lehfilcon A) soft contact lens (CL) with SMARTSURFACE Technology and UV protection
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
, silicone hydrogel (lehfilcon A) soft contact lens (CL) with SMARTSURFACE Technology and UV protectionDevice
Also called P1 Toric Contact lenses
This soft contact lens was designed specifically for those with astigmatism and providing maximum comfort and effectiveness of the lenses.
| Study group | Role | What they receive |
|---|---|---|
| P1 Toric | Experimental | Participants will be refit and provided with P1 toric contact lenses. Receives: Device: , silicone hydrogel (lehfilcon A) soft contact lens (CL) with SMARTSURFACE Technology and UV protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who have satisfied Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores (scores <12).
The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) is a comfort survey with a 0-37 range with lower scores being better. The proportion of study participants who have scores <12 will be reported.
Measured: 1 month
Likert survey
- Likelihood of continuing to wear the study CLs.
- Overall satisfaction while wearing the study CLs.
- Overall vision while wearing the study CLs.
- End of day comfort while wearing the study CLs.
- End of day vision while wearing the study CLs.
- Overall comfort while wearing the study CLs.
- Ability to play sports and perform fitness actives while wearing the study CLs.
- Ability to use digital devices while wearing the study CLs.
- Would recommend the study CLs to a friend
Measured: 1 month
Likert Scale
Frequency of participants who have positive VAS scores based upon a ±50 VAS (end of day comfort; clarity of vision).
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 posted4 Nov 2026
- Study start27 May 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will be refit into P1 Toric contact lenses
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
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
- NCT07914959
- Sponsor's protocol ID
- P1-Toric IRB00006763
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Verofilcon A Toric Contact Lenses in Satisfied Wearers of Senofilcon A Toric Contact Lenses With Blue Light Filtration
- ClinicalTrials.gov ID
- NCT07914959
- Acronym / sponsor ID
- P1-Toric IRB00006763
- Conditions
- Eye, Astigmatism, Contact Lenses
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 27 May 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 4 Nov 2026 (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.
This study aims to determine if participants who are currently wearing Max1day contact lenses can successfully be refit into P1 for astigmatism contact lenses.
Detailed description
This one month 4 visit study will determine if participants who are current Max1day contact lens wearers are able to be refit into P1 for astigmatism contact lenses. P1 Toric contact lenses are designed to promote stable Toric axis during wear. This stands to benefit daily disposable contact lens wearers who have astigmatism. Because this technology is relatively new there is currently a lack of literature regarding comfortability and wear during the day. Therefore, this study aims to determine if current wearers of Max 1day contact lenses can be refit into the new P1 Toric contact lenses.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will be refit into P1 Toric contact lenses
| Arm | Type | Receives |
|---|---|---|
| P1 Toric | Experimental | Device: , silicone hydrogel (lehfilcon A) soft contact lens (CL) with SMARTSURFACE Technology and UV protectionParticipants will be refit and provided with P1 toric contact lenses. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults, 18- to 40-year-old, current CL wearers who have best corrected 20/20 visual acuity or better
- Participants will be required to have worn MAX 1-Day for ASTIGMATISM CLs for at least 3 months in the past year and be currently wearing these CLs.
- All participants will be required to have a CLDEQ-8 score <12 while wearing their habitual CLs.
- Participants will be required to be able to wear P1 for Astigmatism and MAX 1-Day for ASTIGMATISM (astigmatism ≥0.75D OD/OS).
- Astigmatism ranging from 0.75 D to 2.50 D in each eye.
Key exclusion criteria (10 listed)
- Are past rigid CL wearers.
- 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.
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 |
|---|---|---|
| , silicone hydrogel (lehfilcon A) soft contact lens (CL) with SMARTSURFACE Technology and UV protectionAlso: P1 Toric Contact lensesThis soft contact lens was designed specifically for those with astigmatism and providing maximum comfort and effectiveness of the lenses. | Device | P1 Toric |
Primary outcome
Proportion of participants who have satisfied Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores (scores <12).
Time frame: 1 month
The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) is a comfort survey with a 0-37 range with lower scores being better. The proportion of study participants who have scores <12 will be reported.
Likert survey
Time frame: 1 month
1. Likelihood of continuing to wear the study CLs. 2. Overall satisfaction while wearing the study CLs. 3. Overall vision while wearing the study CLs. 4. End of day comfort while wearing the study CLs. 5. End of day vision while wearing the study CLs. 6. Overall comfort while wearing the study CLs. 7. Ability to play sports and perform fitness actives while wearing the study CLs. 8. Ability to use digital devices while wearing the study CLs. 9. Would recommend the study CLs to a friend
Likert Scale
Time frame: 1 month
Frequency of participants who have positive VAS scores based upon a ±50 VAS (end of day comfort; clarity of vision).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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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 , silicone hydrogel (lehfilcon A) soft contact lens (CL) with SMARTSURFACE Technology and UV protection in people with Eye and Astigmatism, 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 8 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of participants who have satisfied Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores (scores <12). (time frame: 1 month). The study lists 3 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 4 Nov 2026; AzTrials last refreshed its copy on 4 Nov 2026.