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Active, not recruitingNCT07914959Updated Nov 4, 2026

P1 Toric Vs. Max 1day

An interventional study of , silicone hydrogel (lehfilcon A) soft contact lens (CL) with SMARTSURFACE Technology and UV protection in Eye, Astigmatism and Contact Lenses, sponsored by Southern College of Optometry. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Southern College of Optometry · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2026, registered Oct 2026).
Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Eye
  • Astigmatism
  • Contact Lenses

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03

In context

Astigmatism

417 studies on the registry are indexed under Astigmatism; 50 are open to participants now.

This study's planned enrollment of 32 is below the median of 55 across 325 interventional studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

Southern College of Optometry is the lead sponsor of 18 studies on the registry; 10 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults, 18- to 40-year-old, current CL wearers who have best corrected 20/20 visual acuity or better
  2. 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.
  3. All participants will be required to have a CLDEQ-8 score \<12 while wearing their habitual CLs.
  4. Participants will be required to be able to wear P1 for Astigmatism and MAX 1-Day for ASTIGMATISM (astigmatism ≥0.75D OD/OS).
  5. Astigmatism ranging from 0.75 D to 2.50 D in each eye.
  6. Participants will be required to wear the study CLs for ≥12 hours each day with no overnight wear.
  7. Participants will be willing to wear the CL every day of the week.
  8. Participants will be required to provide a glasses prescription that is less than 3 years old.

Exclusion criteria

Exclusion Criteria:

  1. Are past rigid CL wearers.
  2. Have a history of being diagnosed with dry eye or ocular allergies.
  3. Have known systemic health conditions that are thought to alter tear film physiology.
  4. Have a history of viral eye disease.
  5. Have a history of ocular surgery.
  6. Have a history of severe ocular trauma.
  7. Have a history of corneal dystrophies or degenerations.
  8. Have active ocular infection or inflammation.
  9. Are currently using isotretinoin-derivatives or ocular medications.
  10. Are pregnant or breast feeding.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    P1 Toric

    Participants will be refit and provided with P1 toric contact lenses.

    Device: , silicone hydrogel (lehfilcon A) soft contact lens (CL) with SMARTSURFACE Technology and UV protection

Interventions

  • Device, silicone hydrogel (lehfilcon A) soft contact lens (CL) with SMARTSURFACE Technology and UV protection

    This soft contact lens was designed specifically for those with astigmatism and providing maximum comfort and effectiveness of the lenses.

    Also known as: P1 Toric Contact lenses

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

  2. Likert survey

    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

    Time frame: 1 month

  3. Likert Scale

    Frequency of participants who have positive VAS scores based upon a ±50 VAS (end of day comfort; clarity of vision).

    Time frame: 1 month

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Nov 2026, 5 months after the start.

Of 77 non-industry interventional studies with no phase under Astigmatism, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's planned 5 months is below that.

Counting every sponsor, half of 183 studies reached it within 12 months; a quarter within 4 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Nov 4, 2026
StartActual
May 27, 2026
Primary completionEst.
Nov 15, 2026
CompletionEst.
Nov 30, 2026
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07914959
Lead sponsor
Southern College of Optometry
Collaborators
Alcon Research
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
May 27, 2026
Primary completion
Nov 15, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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